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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 K920119
Device Name 3M DENTAL ELECTRONIC ANESTHESIA SYSTEM
Applicant
3M Company
Chemolite Blvd. & Washington
City Rd. 19
Cottae Grove,  MN  55016
Applicant Contact PAUL A BURGIO
Correspondent
3M Company
Chemolite Blvd. & Washington
City Rd. 19
Cottae Grove,  MN  55016
Correspondent Contact PAUL A BURGIO
Classification Product Code
LWM  
Date Received01/10/1992
Decision Date 05/22/1992
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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