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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mask, Surgical
510(k) Number K891141
Device Name CARERITE FACE MASK
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 Number878.4040
Classification Product Code
FXX  
Date Received03/03/1989
Decision Date 04/18/1989
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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