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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 K910625
Device Name ULTRACALM
Applicant
Sion Technology, Inc.
1390 S. Potomac St. -
110
Aurora,  CO  80012
Applicant Contact MICHAEL W O'NEILL
Correspondent
Sion Technology, Inc.
1390 S. Potomac St. -
110
Aurora,  CO  80012
Correspondent Contact MICHAEL W O'NEILL
Classification Product Code
LWM  
Date Received02/12/1991
Decision Date 05/15/1992
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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