Device Classification Name |
suture, nonabsorbable, synthetic, polyethylene
|
510(k) Number |
K955747 |
Device Name |
USSC NONABSORBABLE SUTURES |
Applicant |
UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC |
150 GLOVER AVE. |
NORWALK,
CT
06856
|
|
Applicant Contact |
JONATHAN GILBERT |
Correspondent |
UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC |
150 GLOVER AVE. |
NORWALK,
CT
06856
|
|
Correspondent Contact |
JONATHAN GILBERT |
Regulation Number | 878.5000
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 12/19/1995 |
Decision Date | 02/27/1996 |
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
|
Recalls |
CDRH Recalls
|