Device Classification Name |
Restraint, Protective
|
510(k) Number |
K963436 |
Device Name |
RESTRAINT ACCESSORIES |
Applicant |
J. T. POSEY CO. |
5635 PECK RD. |
ARCADIA,
CA
91006
|
|
Applicant Contact |
MICHAEL KEEFE |
Correspondent |
J. T. POSEY CO. |
5635 PECK RD. |
ARCADIA,
CA
91006
|
|
Correspondent Contact |
MICHAEL KEEFE |
Regulation Number | 880.6760
|
Classification Product Code |
|
Date Received | 08/30/1996 |
Decision Date | 11/22/1996 |
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
|
Recalls |
CDRH Recalls
|
|
|