Device Classification Name |
Mesh, Surgical
|
510(k) Number |
K021056 |
Device Name |
PERMACOL |
Applicant |
TISSUE SCIENCE LABORATORIES, PLC |
555 THIRTEENTH ST. N.W. |
WASHINGTON,
DC
20004 -1109
|
|
Applicant Contact |
HOWARD M HOLSTEIN |
Correspondent |
TISSUE SCIENCE LABORATORIES, PLC |
555 THIRTEENTH ST. N.W. |
WASHINGTON,
DC
20004 -1109
|
|
Correspondent Contact |
HOWARD M HOLSTEIN |
Regulation Number | 878.3300
|
Classification Product Code |
|
Date Received | 04/01/2002 |
Decision Date | 10/31/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|