Device Classification Name |
bed, manual
|
510(k) Number |
K823821 |
Device Name |
SIDE RAIL PADS |
Applicant |
DANEK MEDICAL, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
DANEK MEDICAL, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 880.5120
|
Classification Product Code |
|
Date Received | 12/17/1982 |
Decision Date | 01/21/1983 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|