Device Classification Name |
Restraint, Protective
|
510(k) Number |
K963468 |
Device Name |
RESTRICTIVE LIMB HOLDER |
Applicant |
DEROYAL INDUSTRIES, INC. |
200 DEBUSK LN. |
POWELL,
TN
37849
|
|
Applicant Contact |
CAMILLE MATLOCK |
Correspondent |
DEROYAL INDUSTRIES, INC. |
200 DEBUSK LN. |
POWELL,
TN
37849
|
|
Correspondent Contact |
CAMILLE MATLOCK |
Regulation Number | 880.6760
|
Classification Product Code |
|
Date Received | 09/03/1996 |
Decision Date | 01/22/1997 |
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
|
|
|