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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Assembly, Tube Housing, X-Ray, Diagnostic
510(k) Number K894742
Device Name RELOADING OF X-RAY TUBE HOUSING ASSEM., VARIOUS
Applicant
Inmark Corp.
4 Byington Pl.
Norwalk,  CT  06850
Applicant Contact WILLIAM LYONS
Correspondent
Inmark Corp.
4 Byington Pl.
Norwalk,  CT  06850
Correspondent Contact WILLIAM LYONS
Regulation Number892.1760
Classification Product Code
ITY  
Date Received07/17/1989
Decision Date 10/27/1989
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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