BIO-GIDE RESORBABLE BILAYER MEMBRANE


Device Classification Name

barrier, synthetic, intraoral

510(k) Number K960724
Device Name BIO-GIDE RESORBABLE BILAYER MEMBRANE
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

Correspodent Contact peter s reichertz
Regulation Number 872.3930
Classification Product Code
NPK  
Date Received 02/22/1996
Decision Date 06/11/1997
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No