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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, Operative Dental
510(k) Number K983661
Device Name BELMONT UNIT, MODEL 6000 SERIES AND 7500 SERIES
Applicant
Belmont Equipment Corp.
101 Belmont Dr.
Somerset,  NJ  08873
Applicant Contact JOHN E COLLINS
Correspondent
Belmont Equipment Corp.
101 Belmont Dr.
Somerset,  NJ  08873
Correspondent Contact JOHN E COLLINS
Regulation Number872.6640
Classification Product Code
EIA  
Date Received10/19/1998
Decision Date 01/12/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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