Device Classification Name |
Suture, Nonabsorbable, Synthetic, Polypropylene
|
510(k) Number |
K010909 |
Device Name |
NONABSORBABLE POLYPROPYLENE SURGICAL SUTURE |
Applicant |
TYCO HEALTHCARE GROUP, LP |
150 GLOVER AVE. |
NORWALK,
CT
06856
|
|
Applicant Contact |
ROBERT ZOTT |
Correspondent |
TYCO HEALTHCARE GROUP, LP |
150 GLOVER AVE. |
NORWALK,
CT
06856
|
|
Correspondent Contact |
ROBERT ZOTT |
Regulation Number | 878.5010
|
Classification Product Code |
|
Date Received | 03/26/2001 |
Decision Date | 04/09/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|