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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Thermographic, Liquid Crystal, Powered (Adjunctive Use)
510(k) Number K851034
Device Name NOVATHERM
Applicant
Medtech Products, Inc.
Mcdermott, Will & Emery
1850 K St. NW
Washington,  DC  20006
Applicant Contact WILLIAM D APPLER
Correspondent
Medtech Products, Inc.
Mcdermott, Will & Emery
1850 K St. NW
Washington,  DC  20006
Correspondent Contact WILLIAM D APPLER
Regulation Number884.2982
Classification Product Code
KXZ  
Date Received03/13/1985
Decision Date 09/27/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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