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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Remover, Crown
510(k) Number K863500
Device Name STAINLESS STEEL DEN. CROWN REMOVER & AMA./COMP.CAR
Applicant
Pacific Union Dental, Inc.
P.O. Box 2025
Silver Spring,  MD  20902
Applicant Contact KENNETH WOO
Correspondent
Pacific Union Dental, Inc.
P.O. Box 2025
Silver Spring,  MD  20902
Correspondent Contact KENNETH WOO
Regulation Number872.4565
Classification Product Code
EIS  
Date Received09/09/1986
Decision Date 09/22/1986
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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