Device Classification Name |
Mesh, Surgical, Polymeric
|
510(k) Number |
K962530 |
FOIA Releasable 510(k) |
K962530
|
Device Name |
PROLENE POLYPROPYLENE MESH NONABSORBABLE SYNTHETIC SURGICAL MESH |
Applicant |
ETHICON, INC. |
ROUTE 22 WEST |
P.O. BOX 151 |
SOMERVILLE,
NJ
08876 -0151
|
|
Applicant Contact |
JOHN D PAULSON, PH.D. |
Correspondent |
ETHICON, INC. |
ROUTE 22 WEST |
P.O. BOX 151 |
SOMERVILLE,
NJ
08876 -0151
|
|
Correspondent Contact |
JOHN D PAULSON, PH.D. |
Regulation Number | 878.3300
|
Classification Product Code |
|
Date Received | 06/28/1996 |
Decision Date | 08/09/1996 |
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
|
|
|