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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Continuous Measurement Thermometer
510(k) Number K895137
Device Name DIOTHERM
Applicant
SCIENCE REGULATORY SERVICES INTL.
SUITE 975
1625 K STREET, NW
WASHINGTON,  DC  20006
Applicant Contact MICHAEL FARROW
Correspondent
SCIENCE REGULATORY SERVICES INTL.
SUITE 975
1625 K STREET, NW
WASHINGTON,  DC  20006
Correspondent Contact MICHAEL FARROW
Regulation Number880.2910
Classification Product Code
FLL  
Date Received08/16/1989
Decision Date 11/16/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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