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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Diamond, Dental
510(k) Number K934981
Device Name DENTAL DRILL
Applicant
Eare Consulting Service
P.O. Box 1309
Eilat,  IL 88112
Applicant Contact EMANUEL A ROSEN
Correspondent
Eare Consulting Service
P.O. Box 1309
Eilat,  IL 88112
Correspondent Contact EMANUEL A ROSEN
Regulation Number872.4535
Classification Product Code
DZP  
Date Received10/19/1993
Decision Date 02/03/1994
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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