BIOMEND EXTEND ABSORBABLE COLLAGEN MEMBRANE, BIOMEND ABSORBABLE COLLAGEN MENBRANE


Device Classification Name

bone grafting material, synthetic

510(k) Number K992216
Device Name BIOMEND EXTEND ABSORBABLE COLLAGEN MEMBRANE, BIOMEND ABSORBABLE COLLAGEN MENBRANE
Applicant
INTEGRA LIFESCIENCES CORP.
105 morgan ln.
plainsboro, 
NJ 
08536

Applicant Contact judith e o’grady
Correspondent
INTEGRA LIFESCIENCES CORP.
105 morgan ln.
plainsboro, 
NJ 
08536

Correspodent Contact judith e o’grady
Regulation Number 872.3930
Classification Product Code
LYC  
Date Received 07/01/1999
Decision Date 07/26/1999
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls