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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dam, Rubber
510(k) Number K890667
Device Name RUBBER DAM
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 Number872.6300
Classification Product Code
EIE  
Date Received02/09/1989
Decision Date 03/29/1989
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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