Device Classification Name |
Mesh, Surgical, Polymeric
|
510(k) Number |
K810428 |
FOIA Releasable 510(k) |
K810428
|
Device Name |
VICRYL |
Applicant |
ETHICON, INC. |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Correspondent |
ETHICON, INC. |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Regulation Number | 878.3300
|
Classification Product Code |
|
Date Received | 02/18/1981 |
Decision Date | 03/13/1981 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|