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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 K962666
Device Name BEMISS JASON-STERILE,NON-STERILE,REINFORCED STERILE,AND REINFORCED NON-STERILE SURGICAL GOWN
Applicant
Bemiss-Jason Corp., Triad Medical Div.
405 Walnut St., P.O. Box 1436
Waynesville,  NC  28786
Applicant Contact SANDRA MCGEE
Correspondent
Bemiss-Jason Corp., Triad Medical Div.
405 Walnut St., P.O. Box 1436
Waynesville,  NC  28786
Correspondent Contact SANDRA MCGEE
Regulation Number878.4040
Classification Product Code
FYA  
Date Received07/09/1996
Decision Date 02/27/1997
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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