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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Locator, Root Apex
510(k) Number K030895
Device Name ASEPTICO ENDOPEX V, MODEL AEU-40
Applicant
Aseptico, Inc.
8333 216th St. SE
Woodinville,  WA  98072
Applicant Contact GRANT RAMALEY
Correspondent
Aseptico, Inc.
8333 216th St. SE
Woodinville,  WA  98072
Correspondent Contact GRANT RAMALEY
Classification Product Code
LQY  
Date Received03/21/2003
Decision Date 12/03/2003
Decision Substantially Equivalent (SESE)
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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