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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 K912338
Device Name TUBE HOUSING ASSEMBLIES
Applicant
COMET LTD. C/O RADIOLOGY RESOURCES, INC.
WALDEGGSTRASSE 72
CH-3097 LIEBEFELD-BERNE
SWITZERLAND,  CH
Applicant Contact FREY
Correspondent
COMET LTD. C/O RADIOLOGY RESOURCES, INC.
WALDEGGSTRASSE 72
CH-3097 LIEBEFELD-BERNE
SWITZERLAND,  CH
Correspondent Contact FREY
Regulation Number892.1760
Classification Product Code
ITY  
Date Received05/24/1991
Decision Date 08/07/1991
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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