Device Classification Name |
Gown, Surgical
|
510(k) Number |
K121664 |
Device Name |
T4/T5 HYTREL TOGAS |
Applicant |
STRYKER CORPORATION |
4100 E. MILHAM AVE |
KALAMAZOO,
MI
49001
|
|
Applicant Contact |
CASEY A METZGER |
Correspondent |
STRYKER CORPORATION |
4100 E. MILHAM AVE |
KALAMAZOO,
MI
49001
|
|
Correspondent Contact |
CASEY A METZGER |
Regulation Number | 878.4040
|
Classification Product Code |
|
Date Received | 06/05/2012 |
Decision Date | 03/10/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General Hospital
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|