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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Temperature Measurement, Direct Contact, Powered
510(k) Number K974208
Device Name TYTRON C-3000
Applicant
Titronics Research & Development Co.
2046 Redwing Hollow SW
Oxford,  IA  52322
Applicant Contact JOSEPH R TITONE
Correspondent
Titronics Research & Development Co.
2046 Redwing Hollow SW
Oxford,  IA  52322
Correspondent Contact JOSEPH R TITONE
Regulation Number882.1570
Classification Product Code
HCS  
Date Received11/10/1997
Decision Date 02/03/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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