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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Grid, Radiographic
510(k) Number K954294
Device Name HIGH TRANSMISSION CELLULAR (HTC) GRIDS 18X24 CM & 24X30 CM SIZES
Applicant
Thermotrex Corp.
36 Apple Ridge Rd.
Danbury,  CT  06810
Applicant Contact JEFFREY MOELLER
Correspondent
Thermotrex Corp.
36 Apple Ridge Rd.
Danbury,  CT  06810
Correspondent Contact JEFFREY MOELLER
Regulation Number892.1910
Classification Product Code
IXJ  
Date Received09/14/1995
Decision Date 02/02/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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