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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Marker, Radiographic, Implantable
510(k) Number K042341
Device Name ULTRACLIP II US
Applicant
Inrad
4375 Donker Ct. SE
Kentwood,  MI  49512
Applicant Contact MELISSA LALOMIA
Correspondent
Inrad
4375 Donker Ct. SE
Kentwood,  MI  49512
Correspondent Contact MELISSA LALOMIA
Regulation Number878.4300
Classification Product Code
NEU  
Subsequent Product Code
GDW  
Date Received08/30/2004
Decision Date 09/20/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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