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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Collimator, Manual, Radiographic
510(k) Number K780736
Device Name CT 5221 DOSE REDUCING COLLIMATORS
Applicant
Emi Medical, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Emi Medical, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number892.1610
Classification Product Code
IZX  
Date Received05/01/1978
Decision Date 06/02/1978
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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