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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, Operative Dental
510(k) Number K905401
Device Name ASEPTIMINI UNIT, ADU-10
Applicant
Aseptico, Inc.
P.O. Box 3209
Kirkland,  WA  98083
Applicant Contact GLEN KAZEN
Correspondent
Aseptico, Inc.
P.O. Box 3209
Kirkland,  WA  98083
Correspondent Contact GLEN KAZEN
Regulation Number872.6640
Classification Product Code
EIA  
Date Received12/03/1990
Decision Date 02/20/1991
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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