| 510(k) Number |
K902682 |
| Device Name |
STICK-GARD STERILE CAP |
| Applicant |
| Integrated Medical Systems, Inc. |
| 1886 Santa Anita Ave., |
|
South El Monte,
CA
91733
|
|
| Applicant Contact |
ANN L NADLER |
| Correspondent |
| Integrated Medical Systems, Inc. |
| 1886 Santa Anita Ave., |
|
South El Monte,
CA
91733
|
|
| Correspondent Contact |
ANN L NADLER |
| Classification Product Code |
|
| Date Received | 06/19/1990 |
| Decision Date | 09/26/1990 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
General Hospital
|
| 510k Review Panel |
General & Plastic Surgery
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|