T4/T5 HYTREL TOGAS


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

Correspodent Contact casey a metzger
Regulation Number 878.4040
Classification Product Code
FYA  
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