DURA BLUE STERILIZATION WRAP


Device Classification Name

wrap, sterilization

510(k) Number K112211
Device Name DURA BLUE STERILIZATION WRAP
Applicant
CARDINAL HEALTH 200, LLC
1430 waukegaan road
waukegan, 
IL 
60085

Applicant Contact lavenia ford
Regulation Number 880.6850
Classification Product Code
FRG  
Date Received 08/02/2011
Decision Date 10/20/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General Hospital

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No