FDA 510(k) Application Details - K100624

Device Classification Name Colonoscope And Accessories, Flexible/Rigid

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510(K) Number K100624
Device Name Colonoscope And Accessories, Flexible/Rigid
Applicant INVENDO MEDICAL GBMH
PETERHOFSTRAUSSE 3B
KISSING 86438 DE
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Contact OLIVER V RUEPPRECHT
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Regulation Number 876.1500

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Classification Product Code FDF
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Date Received 03/04/2010
Decision Date 02/23/2012
Decision SESE - SUBST EQUIV
Classification Advisory Committee GU - Gastroenterology & Urology
Review Advisory Committee GU - Gastroenterology & Urology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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