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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 K002258
Device Name ULTRAGUIDE CT-GUIDE 1010
Applicant
Ultraguide , Ltd.
377 Rte. 17 S.
Hasbrouck Heights,  NJ  07601
Applicant Contact GEORGE MYERS
Correspondent
Citech
5200 Butler Pike
Plymouth Meeting,  PA  19462
Correspondent Contact ROBERT MOSENKIS
Regulation Number892.1750
Classification Product Code
JAK  
Date Received07/25/2000
Decision Date 08/08/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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