| Device Classification Name |
Bed, Ac-Powered Adjustable Hospital
|
| 510(k) Number |
K951735 |
| Device Name |
JOERNS HEALTHCARE, INC. FULL LENGTH TELESCOPING RAIL |
| Applicant |
| Joerns Healthcare, Inc. |
| 5001 Joerns Dr. |
|
Stevens Point,
WI
54481 -5040
|
|
| Applicant Contact |
MARK GRACE |
| Correspondent |
| Joerns Healthcare, Inc. |
| 5001 Joerns Dr. |
|
Stevens Point,
WI
54481 -5040
|
|
| Correspondent Contact |
MARK GRACE |
| Regulation Number | 880.5100 |
| Classification Product Code |
|
| Date Received | 04/14/1995 |
| Decision Date | 08/18/1995 |
| 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
|
| Recalls |
CDRH Recalls
|
|
|