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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Beam Limiting, X-Ray, Diagnostic
510(k) Number K904587
Device Name DENSICOMP 250
Applicant
L. Keroack Co.
4841 Wilson St.
Montreal, Qc,
Canada H3x 3p3,  CA
Applicant Contact LUCIEN KEROACK
Correspondent
L. Keroack Co.
4841 Wilson St.
Montreal, Qc,
Canada H3x 3p3,  CA
Correspondent Contact LUCIEN KEROACK
Regulation Number892.1610
Classification Product Code
KPW  
Date Received10/09/1990
Decision Date 01/24/1991
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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