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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cuvette, Thermostated
510(k) Number K780888
Device Name THERMO SET ELECTRONIC TEM. CONTROLLER
Applicant
Gilford Instrument Laboratories, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Gilford Instrument Laboratories, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number862.2050
Classification Product Code
JRI  
Date Received05/26/1978
Decision Date 06/28/1978
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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