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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 K093787
Device Name IGUIDE CAPPA
Applicant
Cas Innovations GmbH & Co. KG
Amstel 320-I
Amsterdam, Nh,  NL 1017AP
Applicant Contact ANGELIKA SCHERP
Correspondent
Cas Innovations GmbH & Co. KG
Amstel 320-I
Amsterdam, Nh,  NL 1017AP
Correspondent Contact ANGELIKA SCHERP
Regulation Number892.1750
Classification Product Code
JAK  
Subsequent Product Codes
GAA   OAR  
Date Received12/09/2009
Decision Date 03/11/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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