| Device Classification Name |
Stand, Infusion
|
| 510(k) Number |
K946201 |
| Device Name |
STAND, INFUSION |
| Applicant |
| Medical Specialties, Inc. |
| 58 Norfolk Ave. |
|
South Easton,
MA
02375
|
|
| Applicant Contact |
JOHN WHISNANT |
| Correspondent |
| Medical Specialties, Inc. |
| 58 Norfolk Ave. |
|
South Easton,
MA
02375
|
|
| Correspondent Contact |
JOHN WHISNANT |
| Regulation Number | 880.6990 |
| Classification Product Code |
|
| Date Received | 12/21/1994 |
| Decision Date | 04/18/1995 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
General Hospital
|
| 510k Review Panel |
General Hospital
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|