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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Needle, Dental
510(k) Number K914562
Device Name ASEPTIC DENTAL TECH. TOTAL TREATMENT SYSTEM
Applicant
Aseptic Dental Technologies, Inc.
615 Mayfair
Arlington Heights,  IL  60005
Applicant Contact DAVID RUGGIO
Correspondent
Aseptic Dental Technologies, Inc.
615 Mayfair
Arlington Heights,  IL  60005
Correspondent Contact DAVID RUGGIO
Regulation Number872.4730
Classification Product Code
DZM  
Date Received10/15/1991
Decision Date 03/09/1992
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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