GEISTLICH PERIO-SYSTEM COMBI-PACK , GEISTLICH BIO-GIDE PERIO

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 Perio-system Combi-pack , Geistlich Bio-gide Perio.

Pre-market Notification Details

Device IDK112575
510k NumberK112575
Device Name:GEISTLICH PERIO-SYSTEM COMBI-PACK , GEISTLICH BIO-GIDE PERIO
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 Date2011-12-27
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
07610221010394 K112575 000

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