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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 K871798
Device Name FILM AND PAPER COMBINATION STERILIZING BAG
Applicant
Cost Rite Health Products, Inc.
9428 Eton Ave. Unit "F"
Chatsworth,  CA  91311
Applicant Contact BEN-TZUR
Correspondent
Cost Rite Health Products, Inc.
9428 Eton Ave. Unit "F"
Chatsworth,  CA  91311
Correspondent Contact BEN-TZUR
Regulation Number880.6850
Classification Product Code
FRG  
Date Received05/07/1987
Decision Date 07/21/1987
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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