| 510(k) Number |
K862335 |
| Device Name |
MODIFIED I.V. START, RE-START, PEDI AND GERI-KIT |
| Applicant |
| U.S. Mfg. & Management, Inc. |
| 287 S. Stoddard Ave. |
|
San Bernardino,
CA
92401
|
|
| Applicant Contact |
FRANK J RAUSCHER |
| Correspondent |
| U.S. Mfg. & Management, Inc. |
| 287 S. Stoddard Ave. |
|
San Bernardino,
CA
92401
|
|
| Correspondent Contact |
FRANK J RAUSCHER |
| Date Received | 06/19/1986 |
| Decision Date | 07/24/1986 |
| Decision |
SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS
(SN) |
| 510k Review Panel |
General & Plastic Surgery
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|