Device Classification Name |
Drape, Surgical
|
510(k) Number |
K970185 |
Device Name |
STERILE DISPOSABLE EQUIPMENT MAGNET COVER |
Applicant |
CONTOUR FABRICATORS, INC. |
4100 E. BALDWIN AVE. |
GRAND BLANC,
MI
48439
|
|
Applicant Contact |
MICHAEL CZOP |
Correspondent |
CONTOUR FABRICATORS, INC. |
4100 E. BALDWIN AVE. |
GRAND BLANC,
MI
48439
|
|
Correspondent Contact |
MICHAEL CZOP |
Regulation Number | 878.4370
|
Classification Product Code |
|
Date Received | 01/17/1997 |
Decision Date | 04/10/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|