Device Classification Name |
Suture, Nonabsorbable, Silk
|
510(k) Number |
K942234 |
Device Name |
VISITEC PRECISE-POINT |
Applicant |
VISITEC CO. |
7575 COMMERCE COURT |
SARASOTA,
FL
34243 -3218
|
|
Applicant Contact |
DAVID A CLAPP |
Correspondent |
VISITEC CO. |
7575 COMMERCE COURT |
SARASOTA,
FL
34243 -3218
|
|
Correspondent Contact |
DAVID A CLAPP |
Regulation Number | 878.5030 |
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 05/09/1994 |
Decision Date | 07/12/1994 |
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
|
Predetermined Change Control Plan Authorized |
No
|