STRYKER T4 URETHANE HOOD; STRYKER T4 URETHANE ZIPPER TOGA; STRYKER T4 URETHANE PULLOVER TOGA


Device Classification Name

gown, surgical

510(k) Number K022162
Device Name STRYKER T4 URETHANE HOOD; STRYKER T4 URETHANE ZIPPER TOGA; STRYKER T4 URETHANE PULLOVER TOGA
Original Applicant
STRYKER INSTRUMENTS
4100 east milham ave.
kalamazoo, 
MI 
49001

Original Contact dannielle wheeler
Regulation Number 878.4040
Classification Product Code
FYA  
Subsequent Product Codes
FXY   LYU  
Date Received 07/03/2002
Decision Date 08/01/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

General Hospital

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No