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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Burnisher, Operative
510(k) Number K932511
Device Name SILICONE MIRROR
Applicant
Moyco Industries, Inc.
2054 W. Clearfield St.
Philadelphia,  PA  19132
Applicant Contact CHRIS M LEHR
Correspondent
Moyco Industries, Inc.
2054 W. Clearfield St.
Philadelphia,  PA  19132
Correspondent Contact CHRIS M LEHR
Regulation Number872.4565
Classification Product Code
EKJ  
Date Received05/25/1993
Decision Date 11/05/1993
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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