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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 K080723
Device Name SRI LP GOWN
Applicant
Sri/Surgical Express, Inc.
P.O. Box 92493
Austin,  TX  78709
Applicant Contact JEFFERY O STULL
Correspondent
Sri/Surgical Express, Inc.
P.O. Box 92493
Austin,  TX  78709
Correspondent Contact JEFFERY O STULL
Regulation Number878.4040
Classification Product Code
FYA  
Date Received03/12/2008
Decision Date 11/13/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Statement Statement
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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