| 510(k) Number |
K853507 |
| Device Name |
STERI-GRIP |
| Applicant |
| Clinical Technology Corp. |
| 3750 Monroe Ave. |
| P.O. Box 23245 |
|
Rochester,
NY
14692
|
|
| Applicant Contact |
JOHN R SCOVILLE |
| Correspondent |
| Clinical Technology Corp. |
| 3750 Monroe Ave. |
| P.O. Box 23245 |
|
Rochester,
NY
14692
|
|
| Correspondent Contact |
JOHN R SCOVILLE |
| Date Received | 08/21/1985 |
| Decision Date | 09/05/1985 |
| Decision |
Substantially Equivalent
(SESE) |
| 510k Review Panel |
General & Plastic Surgery
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|