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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gown, Isolation, Surgical
510(k) Number K864479
Device Name CARETEX ISOLUTION GOWNS
Applicant
James River Corp.
1915 Marathon Ave.
Neenah,  WI  54956
Applicant Contact RICHARD L DAVIS
Correspondent
James River Corp.
1915 Marathon Ave.
Neenah,  WI  54956
Correspondent Contact RICHARD L DAVIS
Regulation Number878.4040
Classification Product Code
FYC  
Date Received11/13/1986
Decision Date 12/09/1986
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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