ARJORAD STERILE WRAP


Device Classification Name

wrap, sterilization

510(k) Number K110954
Device Name ARJORAD STERILE WRAP
Applicant
ARJO WIGGINS MEDICAL, INC.
962 allegro lane
apollo beach, 
FL 
33572

Applicant Contact jon ward
Correspondent
ARJO WIGGINS MEDICAL, INC.
962 allegro lane
apollo beach, 
FL 
33572

Correspodent Contact jon ward
Regulation Number 880.6850
Classification Product Code
FRG  
Date Received 04/05/2011
Decision Date 08/24/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General Hospital

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No