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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bone Grafting Material, Synthetic
510(k) Number K972817
Device Name RESOR-PIN RESORBABLE MEMBRANE PIN
Applicant
GEISTLICH-PHARMA
1050 CONNECTICUT AVE. N.W.
WASHINGTON,  DC  20036
Applicant Contact PETER S REICHERTZ
Correspondent
GEISTLICH-PHARMA
1050 CONNECTICUT AVE. N.W.
WASHINGTON,  DC  20036
Correspondent Contact PETER S REICHERTZ
Regulation Number872.3930
Classification Product Code
LYC  
Date Received07/29/1997
Decision Date 07/24/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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