Device Classification Name |
restraint, protective
|
510(k) Number |
K963452 |
Device Name |
MEDLINE ZIPPER SLEEVED VEST |
Applicant |
MEDLINE |
ONE MEDLINE PLACE |
MUNDLELEIN,
IL
60060
|
|
Applicant Contact |
LARA N SIMMONS |
Correspondent |
MEDLINE |
ONE MEDLINE PLACE |
MUNDLELEIN,
IL
60060
|
|
Correspondent Contact |
LARA N SIMMONS |
Regulation Number | 880.6760
|
Classification Product Code |
|
Date Received | 09/03/1996 |
Decision Date | 10/18/1996 |
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
|
|
|