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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 K060181
Device Name COMPE1 1 -PLY SURGICAL GOWNS
Applicant
Standard Textile Co., Inc.
One Knollcrest Dr.
Cincinnati,  OH  45237 -1600
Applicant Contact BRADLEY J BUSHMAN
Correspondent
Standard Textile Co., Inc.
One Knollcrest Dr.
Cincinnati,  OH  45237 -1600
Correspondent Contact BRADLEY J BUSHMAN
Regulation Number878.4040
Classification Product Code
FYA  
Date Received01/23/2006
Decision Date 03/07/2006
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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