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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Floss, Dental
510(k) Number K871736
Device Name CARERITE BIOPACK GINGIVAL RETRACTION CORD
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 Number872.6390
Classification Product Code
JES  
Date Received05/05/1987
Decision Date 05/27/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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