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510(k) submission to FDA

German translation: Antrag nach Abschnitt 510(k) des FDCA an die FDA (mit Erläuterungen)

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English term or phrase:	510(k) submission to FDA
German translation:	Antrag nach Abschnitt 510(k) des FDCA an die FDA (mit Erläuterungen)
Entered by:	mia1969

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08:33 Feb 14, 2006

English to German translations [PRO]
Medical - Medical (general) / Food and Drug Administration

English term or phrase: 510(k) submission to FDA

Weiß jemand, ob 510(k) eine besondere Bedeutung hat, oder ob es sich nur um eine Klassifizierung der FDA handelt????

mia1969 KudoZ activity Questions: 177 (7 open) (7 without valid answers) (4 closed without grading) Answers: 0
Local time: 07:05

Antrag nach Abschnitt 510(k) des FDCA an die FDA (mit Erläuterungen)

Explanation:
http://www.510k.org/

der Begriff bezieht sich offensichtlich auf den Abschnitt 510(k) des US-Gesetzes über Lebensmittel, Medikamente und Kosmetik (FDCA).
Man muss anscheinend vor der beabsichtigten Vermarktung von neuen medizinischen Hilfsmitteln und Geräten vorab die Genehmigung der FDA einholen

Selected response from:

Barbara Wiegel
United States
Local time: 01:05

Grading comment

4 KudoZ points were awarded for this answer

Summary of answers provided

3 +1

Antrag nach Abschnitt 510(k) des FDCA an die FDA (mit Erläuterungen)

Barbara Wiegel

Discussion entries: 1

Answers

1 hr confidence:

peer agreement (net): +1

510(k) submission to fda

Antrag nach Abschnitt 510(k) des FDCA an die FDA (mit Erläuterungen)

Barbara Wiegel
United States
Local time: 01:05
Native speaker of: German
PRO pts in category: 8

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510(k) submission to FDA

German translation: Antrag nach Abschnitt 510(k) des FDCA an die FDA (mit Erläuterungen)

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510(k) submission to FDA

German translation: Antrag nach Abschnitt 510(k) des FDCA an die FDA (mit Erläuterungen)

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KudoZ™ translation helpThe KudoZ network provides a framework for translators and others to assist each other with translations or explanations of terms and short phrases.

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