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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 K910842
Device Name DI2000/HS-45-150 X-RAY TUBE INSERT
Applicant
Comet Ltd. C/O Radiology Resources, Inc.
Waldeggstrasse 72
Ch-3097 Liebefeld-Berne
Switzerland,  CH
Applicant Contact SUFFREDINI
Correspondent
Comet Ltd. C/O Radiology Resources, Inc.
Waldeggstrasse 72
Ch-3097 Liebefeld-Berne
Switzerland,  CH
Correspondent Contact SUFFREDINI
Regulation Number892.1760
Classification Product Code
ITY  
Date Received02/27/1991
Decision Date 03/06/1991
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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