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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Electrical Dental Anesthesia
510(k) Number K884586
Device Name COMFORTRON DENTAL ANESTHESIA APPARATUS
Applicant
M. D. Products
2137 SE Fort King
Ocala,  FL  32671
Applicant Contact ROBERT DREYFUS
Correspondent
M. D. Products
2137 SE Fort King
Ocala,  FL  32671
Correspondent Contact ROBERT DREYFUS
Classification Product Code
LWM  
Date Received11/02/1988
Decision Date 04/14/1989
Decision Substantially Equivalent (SESE)
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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