Device Classification Name |
Suture, Nonabsorbable, Synthetic, Polyester
|
510(k) Number |
K923161 |
Device Name |
BRAIDED POLYESTER SUTURE MATERIAL |
Applicant |
MITEK SURGICAL PRODUCTS, INC. |
57 PROVIDENCE HWY. |
NORWOOD,
MA
02062
|
|
Applicant Contact |
ROBERT P ZOLETTI |
Correspondent |
MITEK SURGICAL PRODUCTS, INC. |
57 PROVIDENCE HWY. |
NORWOOD,
MA
02062
|
|
Correspondent Contact |
ROBERT P ZOLETTI |
Regulation Number | 878.5000
|
Classification Product Code |
|
Date Received | 06/29/1992 |
Decision Date | 12/30/1992 |
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
|
|
|