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510(k) K072219

CYTOPHIL TISSUE MARKER by Cytophil, Inc. — Product Code NEU

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 18, 2008
Date Received
August 10, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Marker, Radiographic, Implantable
Device Class
Class II
Regulation Number
878.4300
Review Panel
SU
Submission Type

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  • K093871 — PERIOPHIL B-TCP (April 22, 2010)
  • K092788 — PERIOPHIL BIPHASIC (December 18, 2009)
  • K081816 — VOCALIS AND VOCALIS SM (January 5, 2009)
  • K081815 — VOCALIS GEL (January 5, 2009)

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