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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 K935304
Device Name 3M DENTAL ELECTRONIC ANESTHESIA (DEA) SYSTEM 8670
Applicant
3M COMPANY
LIME ST., P.O. BOX 9
MARBLEHEAD,  MA  01945
Applicant Contact PAUL A BURGIO
Correspondent
3M COMPANY
LIME ST., P.O. BOX 9
MARBLEHEAD,  MA  01945
Correspondent Contact PAUL A BURGIO
Classification Product Code
LWM  
Date Received11/02/1993
Decision Date 03/16/1994
Decision Substantially Equivalent (SESE)
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
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