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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Telethermographic (Adjunctive Use)
510(k) Number K150457
Device Name AlfaSight 9000 Thermographic System
Applicant
Alfa Thermodiagnostics, Inc.
9057 Soquel Dr., Suite B-Aa
Aptos,  CA  95033
Applicant Contact Daniel Beilin
Correspondent
Hogan Lovells US LLP
555 Thirteenth St., NW
Washington, Dc,  DC  20004
Correspondent Contact John J Smith
Regulation Number884.2980
Classification Product Code
LHQ  
Date Received02/20/2015
Decision Date 04/10/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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