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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 K072219
Device Name CYTOPHIL TISSUE MARKER
Applicant
Cytophil, Inc.
5546 N Santa Monica Blvd.
Whitefish Bay,  WI  53217
Applicant Contact Greg Johnson
Correspondent
Cytophil, Inc.
5546 N Santa Monica Blvd.
Whitefish Bay,  WI  53217
Correspondent Contact Greg Johnson
Regulation Number878.4300
Classification Product Code
NEU  
Date Received08/10/2007
Decision Date 01/18/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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