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510(k) K130307

ONCOZENE MICROSPHERES 40UM, 2ML, ONCOZENE MICROSPHERES 75UM, 2ML, ONCOZENE MICROSPHERES 100UM, 2ML, ONCOZENE MICROSPHERE by Celonova Biosciences, Inc. — Product Code KRD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 4, 2013
Date Received
February 7, 2013
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Vascular, For Promoting Embolization
Device Class
Class II
Regulation Number
870.3300
Review Panel
CV
Submission Type

Other clearances by Celonova Biosciences, Inc.

  • K141209 — EMBOZENE COLOR-ADVANCED MICROSPHERES, EMBOZENE OPAQUE (NON-COLORED) MICROSPHERES (August 7, 2014)
  • K133447 — EMBOZENE COLOR-ADVANCED MICROSPHERES, EMBOZENE OPAQUE (NON-COLORED) MICROSPHERES (February 24, 2014)
  • K132675 — EMBOZENE MICROSPHERES (October 3, 2013)
  • K073417 — EMBOZENE MICROSPHERES (December 15, 2008)

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