STRYKER STRI-SHIELD FLYTE TOGAS


Device Classification Name

gown, surgical

510(k) Number K073017
Device Name STRYKER STRI-SHIELD FLYTE TOGAS
Applicant
STRYKER INSTRUMENTS, INSTRUMENTS DIV.
4100 east milham ave.
kalamazoo, 
MI 
49001

Applicant Contact paulette d johnson
Correspondent
STRYKER INSTRUMENTS, INSTRUMENTS DIV.
4100 east milham ave.
kalamazoo, 
MI 
49001

Correspodent Contact paulette d johnson
Regulation Number 878.4040
Classification Product Code
FYA  
Date Received 10/25/2007
Decision Date 11/30/2007
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

Recalls CDRH Recalls