Device Classification Name |
suture, absorbable, synthetic, polyglycolic acid
|
510(k) Number |
K000037 |
Device Name |
MONOFILAMENT BIOSYN SUTURE |
Applicant |
UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC |
150 GLOVER AVE. |
NORWALK,
CT
06856
|
|
Applicant Contact |
SETH A SCHULMAN |
Correspondent |
UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC |
150 GLOVER AVE. |
NORWALK,
CT
06856
|
|
Correspondent Contact |
SETH A SCHULMAN |
Regulation Number | 878.4493
|
Classification Product Code |
|
Date Received | 01/06/2000 |
Decision Date | 03/30/2000 |
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
|