Device Classification Name |
mesh, surgical, polymeric
|
510(k) Number |
K915526 |
Device Name |
COATED SURGIPRO(TM) POLYPROPYLENE SURGICAL MESH |
Applicant |
UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC |
150 GLOVER AVE. |
NORWALK,
CT
06856
|
|
Applicant Contact |
STEVE REITZLER |
Correspondent |
UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC |
150 GLOVER AVE. |
NORWALK,
CT
06856
|
|
Correspondent Contact |
STEVE REITZLER |
Regulation Number | 878.3300
|
Classification Product Code |
|
Date Received | 12/10/1991 |
Decision Date | 05/29/1992 |
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
|
Recalls |
CDRH Recalls
|