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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 K861601
Device Name DP32 HAND HELD DENTAL PROPHYLAXIS UNIT
Applicant
Stewart J. Lustgarten
One Apple Hill Suite 316
Natick,  MA  01760
Applicant Contact STEWART LUSTGARTEN
Correspondent
Stewart J. Lustgarten
One Apple Hill Suite 316
Natick,  MA  01760
Correspondent Contact STEWART LUSTGARTEN
Regulation Number872.6640
Classification Product Code
EIA  
Date Received04/29/1986
Decision Date 10/17/1986
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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