GEISTLICH COMBI-KIT COLLEGEN

Bone Grafting Material, Animal Source

GEISTLICH PHARMA AG

The following data is part of a premarket notification filed by Geistlich Pharma Ag with the FDA for Geistlich Combi-kit Collegen.

Pre-market Notification Details

Device IDK112572
510k NumberK112572
Device Name:GEISTLICH COMBI-KIT COLLEGEN
ClassificationBone Grafting Material, Animal Source
Applicant GEISTLICH PHARMA AG 555 TWELFTH STREET, NW Washington,  DC  20004 -1206
ContactDaniel A Kracov
CorrespondentDaniel A Kracov
GEISTLICH PHARMA AG 555 TWELFTH STREET, NW Washington,  DC  20004 -1206
Product CodeNPM  
CFR Regulation Number872.3930 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-09-06
Decision Date2011-12-28
Summary:summary

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