Device Classification Name |
Suture, Absorbable, Synthetic
|
510(k) Number |
K895579 |
Device Name |
POLYSORB SYNTHETIC ABSORBABLE SUTURE |
Applicant |
UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC |
150 GLOVER AVE. |
NORWALK,
CT
06856
|
|
Applicant Contact |
WALTER S HENNIG |
Correspondent |
UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC |
150 GLOVER AVE. |
NORWALK,
CT
06856
|
|
Correspondent Contact |
WALTER S HENNIG |
Regulation Number | 878.4830
|
Classification Product Code |
|
Date Received | 09/15/1989 |
Decision Date | 07/05/1990 |
Decision |
SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS
(SN) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|