Device Classification Name |
Dressing, Wound, Drug
|
510(k) Number |
K003229 |
Device Name |
BIOPATCH ANTIMICROBIAL DRESSING |
Applicant |
INTEGRA LIFESCIENCES CORP. |
ROUTE 22 |
SOMERVILLE,
NJ
08876
|
|
Applicant Contact |
WILLIAM GOELLER |
Correspondent |
INTEGRA LIFESCIENCES CORP. |
ROUTE 22 |
SOMERVILLE,
NJ
08876
|
|
Correspondent Contact |
WILLIAM GOELLER |
Classification Product Code |
|
Date Received | 10/10/2000 |
Decision Date | 10/26/2001 |
Decision |
Substantially Equivalent
(SESE) |
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|