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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Drill, Dental, Intraoral
510(k) Number K962979
Device Name S-53 INTRORAL DENTAL SYSTEM
Applicant
Del Medical Systems Corp.
One Commerce Park
Valhalla,  NY  10595
Applicant Contact KARL J WEYDIG
Correspondent
Del Medical Systems Corp.
One Commerce Park
Valhalla,  NY  10595
Correspondent Contact KARL J WEYDIG
Regulation Number872.4130
Classification Product Code
DZA  
Date Received07/31/1996
Decision Date 09/25/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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