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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, Tomography, Computed
510(k) Number K052852
FOIA Releasable 510(k) K052852
Device Name SUPERDIMENSION/BRONCHUS PREMIUM
Applicant
Superdimension, Ltd.
377 Route 17s
Hasbrouck Heights,  NJ  07604
Applicant Contact GEORGE MYERS
Correspondent
Superdimension, Ltd.
377 Route 17s
Hasbrouck Heights,  NJ  07604
Correspondent Contact GEORGE MYERS
Regulation Number892.1750
Classification Product Code
JAK  
Date Received10/11/2005
Decision Date 11/14/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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