| Device Classification Name |
Warmer, Thermal, Infusion Fluid
|
| 510(k) Number |
K955659 |
| Device Name |
DRUGBOX |
| Applicant |
| C.F. Electronics, Inc. |
| 5 Brayton Ct. |
|
Commack,
NY
11725
|
|
| Applicant Contact |
ROBERT P FREEDMAN |
| Correspondent |
| C.F. Electronics, Inc. |
| 5 Brayton Ct. |
|
Commack,
NY
11725
|
|
| Correspondent Contact |
ROBERT P FREEDMAN |
| Regulation Number | 880.5725 |
| Classification Product Code |
|
| Date Received | 12/12/1995 |
| Decision Date | 05/14/1996 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
General Hospital
|
| 510k Review Panel |
General Hospital
|
| Summary |
Summary
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|