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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Drape, Surgical, Antimicrobial
510(k) Number K960045
Device Name ENVIROTEX REUSABLE O.R. WRAPPER AND CUSTOM SURGICAL DRAPE
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 Number878.4370
Classification Product Code
KKX  
Date Received01/02/1996
Decision Date 06/05/1996
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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