| Device Classification Name |
Bedding, Disposable, Medical
|
| 510(k) Number |
K853970 |
| Device Name |
ALPHA CHUCK |
| Applicant |
| Rocky Mountain Medical Corp. |
| 5680 S. Syracuse Cir. |
| P.O. Box 4783 |
|
Greenwood Village,
CO
80111
|
|
| Applicant Contact |
RICHARD J ROSENBAUM |
| Correspondent |
| Rocky Mountain Medical Corp. |
| 5680 S. Syracuse Cir. |
| P.O. Box 4783 |
|
Greenwood Village,
CO
80111
|
|
| Correspondent Contact |
RICHARD J ROSENBAUM |
| Regulation Number | 880.6060 |
| Classification Product Code |
|
| Date Received | 09/26/1985 |
| Decision Date | 11/08/1985 |
| 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
|
|
|