DURABLUE STERILIZATION WRAP, MODEL NUMBERS CH100, CH200, CH300, CH400, CH500 AND CH600, STERRAD NX STERILIZATION


Device Classification Name

wrap, sterilization

510(k) Number K122507
Device Name DURABLUE STERILIZATION WRAP, MODEL NUMBERS CH100, CH200, CH300, CH400, CH500 AND CH600, STERRAD NX STERILIZATION
Applicant
CARDINAL HEALTH 200, LLC
1430 waukegan road
waukegan, 
IL 
60085

Applicant Contact lavenia ford
Regulation Number 880.6850
Classification Product Code
FRG  
Date Received 08/17/2012
Decision Date 09/26/2012
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