Device Classification Name |
Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile
|
510(k) Number |
K931915 |
Device Name |
STAINLESS STEEL SUTURE |
Applicant |
SURGIMETRICS INTERNATIONAL, LTD. |
4233 THAMESGATE CLOSE |
NORCROSS,
GA
30092
|
|
Applicant Contact |
RON LAPORTE |
Correspondent |
SURGIMETRICS INTERNATIONAL, LTD. |
4233 THAMESGATE CLOSE |
NORCROSS,
GA
30092
|
|
Correspondent Contact |
RON LAPORTE |
Regulation Number | 878.4495
|
Classification Product Code |
|
Date Received | 04/16/1993 |
Decision Date | 03/03/1994 |
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
|
|
|