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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 K062315
FOIA Releasable 510(k) K062315
Device Name SUPERDIMENSION/BRONCHUS PREMIUM 2
Applicant
SUPERDIMENSION, LTD.
377 ROUTE 17 S
HASBROUCK HEIGHTS,  NJ  07604
Applicant Contact GEORGE MYERS
Correspondent
SUPERDIMENSION, LTD.
377 ROUTE 17 S
HASBROUCK HEIGHTS,  NJ  07604
Correspondent Contact GEORGE MYERS
Regulation Number892.1750
Classification Product Code
JAK  
Date Received08/09/2006
Decision Date 09/08/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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