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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wrap, Sterilization
510(k) Number K883802
Device Name CARETEX CENTRAL SUPPLY WRAP
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 Number880.6850
Classification Product Code
FRG  
Date Received09/07/1988
Decision Date 10/21/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
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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