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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Mammographic
510(k) Number K901997
Device Name X-RAY TUBE HOUSING ASSEMBLY, VARIOUS MODELS
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 Number892.1710
Classification Product Code
IZH  
Date Received05/02/1990
Decision Date 06/06/1990
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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