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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 K770986
Device Name FLEXI-THERM FILM
Applicant
E-Z-Em, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
E-Z-Em, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number884.2982
Classification Product Code
KXZ  
Date Received05/31/1977
Decision Date 09/12/1977
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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