Device Classification Name |
Mesh, Surgical, Polymeric
|
510(k) Number |
K992556 |
Device Name |
PERMACOL |
Applicant |
TISSUE SCIENCE LABORATORIES, PLC |
7124 LA JOLLA BLVD. |
LA JOLLA,
CA
|
|
Applicant Contact |
ALLISON F WREN |
Correspondent |
TISSUE SCIENCE LABORATORIES, PLC |
7124 LA JOLLA BLVD. |
LA JOLLA,
CA
|
|
Correspondent Contact |
ALLISON F WREN |
Regulation Number | 878.3300
|
Classification Product Code |
|
Date Received | 07/30/1999 |
Decision Date | 02/17/2000 |
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
|
|
|