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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 K921158
Device Name O.R./SURGEONS GOWN, ITEM NO. 4950
Applicant
The Sewing Source, Inc.
802 E. Nash St.
P.O. Box 639
Spring Hope,  NC  27882
Applicant Contact JANET SLOAD
Correspondent
The Sewing Source, Inc.
802 E. Nash St.
P.O. Box 639
Spring Hope,  NC  27882
Correspondent Contact JANET SLOAD
Regulation Number878.4040
Classification Product Code
FYA  
Date Received03/04/1992
Decision Date 07/09/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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