| Device Classification Name |
Kit, Surgical Instrument, Disposable
|
| 510(k) Number |
K902441 |
| Device Name |
DISPOSABLE PROCEDURAL TRAYS #CK-XXXXX (VARIOUS) |
| Applicant |
| Currie Medical Specialties, Inc. |
| 730 E. Los Angeles Ave. |
|
Monrovia,
CA
91016
|
|
| Applicant Contact |
WRIGHT |
| Correspondent |
| Currie Medical Specialties, Inc. |
| 730 E. Los Angeles Ave. |
|
Monrovia,
CA
91016
|
|
| Correspondent Contact |
WRIGHT |
| Regulation Number | 878.4800 |
| Classification Product Code |
|
| Date Received | 06/01/1990 |
| Decision Date | 08/23/1990 |
| Decision |
Substantially Equivalent - Kit With Drugs
(SEKD) |
| 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
|