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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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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