Device Classification Name |
Accessory, Surgical Apparel
|
510(k) Number |
K011755 |
Device Name |
STRYKER T4 HYTREL (R) TOGAS |
Applicant |
STRYKER CORP. |
4100 E. MILHAM AVE. |
KALAMAZOO,
MI
49001
|
|
Applicant Contact |
SUZANNE VELASQUEZ |
Correspondent |
STRYKER CORP. |
4100 E. MILHAM AVE. |
KALAMAZOO,
MI
49001
|
|
Correspondent Contact |
SUZANNE VELASQUEZ |
Regulation Number | 878.4040 |
Classification Product Code |
|
Date Received | 06/06/2001 |
Decision Date | 06/22/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General Hospital
|
Statement |
Statement
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|