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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gown, Surgical
510(k) Number K110724
Device Name SURGICAL PROCEDURE PACKS
Applicant
Omnia Spa
11460 N.Meridian St.,
Suite 150
Carmel,  IN  46032
Applicant Contact JAMIE AUSTIN
Correspondent
Omnia Spa
11460 N.Meridian St.,
Suite 150
Carmel,  IN  46032
Correspondent Contact JAMIE AUSTIN
Regulation Number878.4040
Classification Product Code
FYA  
Subsequent Product Codes
FXX   KKX   LRO  
Date Received03/16/2011
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
Predetermined Change
Control Plan Authorized		 No
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