SURGICAL PROCEDURE PACKS


Device Classification Name

gown, surgical

510(k) Number K110724
Device Name SURGICAL PROCEDURE PACKS
Applicant
OMNIA SPA
11460 n meridian street
suite 150
carmel, 
IN 
46032

Applicant Contact jamie austin
Correspondent
OMNIA SPA
11460 n meridian street
suite 150
carmel, 
IN 
46032

Correspodent Contact jamie austin
Regulation Number 878.4040
Classification Product Code
FYA  
Subsequent Product Codes
FXX   KKX   LRO  
Date Received 03/16/2011
Decision Date 06/23/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

General Hospital

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No