Device Classification Name |
Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile
|
510(k) Number |
K991073 |
Device Name |
ACIER SUTURES |
Applicant |
CARDIO THORACIC SYSTEMS |
10600 N. TANTAU AVE. |
CUPERTINO,
CA
95014 -0739
|
|
Applicant Contact |
MICHAEL J BILLIG |
Correspondent |
CARDIO THORACIC SYSTEMS |
10600 N. TANTAU AVE. |
CUPERTINO,
CA
95014 -0739
|
|
Correspondent Contact |
MICHAEL J BILLIG |
Regulation Number | 878.4495
|
Classification Product Code |
|
Date Received | 03/31/1999 |
Decision Date | 07/30/1999 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|