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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Collimator, Automatic, Radiographic
510(k) Number K810590
Device Name P.R.M. 80
Applicant
T.E.M. Instruments , Ltd.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
T.E.M. Instruments , Ltd.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number892.1610
Classification Product Code
IZW  
Date Received03/04/1981
Decision Date 04/10/1981
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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