| Device Classification Name |
Bed, Therapeutic, Ac-Powered, Adjustable Home-Use
|
| 510(k) Number |
K840787 |
| Device Name |
CRAFTMATIC ELECTRIC ADJUSTABLE BED |
| Applicant |
| Contour, Inc. |
| 4221 Richmond Rd., NW |
|
Walker,
MI
49534
|
|
| Correspondent |
| Contour, Inc. |
| 4221 Richmond Rd., NW |
|
Walker,
MI
49534
|
|
| Regulation Number | 880.5100 |
| Classification Product Code |
|
| Date Received | 01/20/1984 |
| Decision Date | 06/13/1984 |
| 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
|
|
|