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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name File, Pulp Canal, Endodontic
510(k) Number K864922
Device Name DENTAL HANDPIECES AND ATTACHMENT
Applicant
E&D Dental Manufacturing Co.
6 Hoffman Pl.
Hillside,  NJ  07205
Applicant Contact ED SPEHAR
Correspondent
E&D Dental Manufacturing Co.
6 Hoffman Pl.
Hillside,  NJ  07205
Correspondent Contact ED SPEHAR
Regulation Number872.4565
Classification Product Code
EKS  
Date Received12/16/1986
Decision Date 02/19/1987
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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