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510(k) K141209

EMBOZENE COLOR-ADVANCED MICROSPHERES, EMBOZENE OPAQUE (NON-COLORED) MICROSPHERES, ONCOZENE MICROSPHERES by Celonova Biosciences, Inc. — Product Code KRD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 7, 2014
Date Received
May 9, 2014
Clearance Type
Traditional
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.

  • K133447 — EMBOZENE COLOR-ADVANCED MICROSPHERES, EMBOZENE OPAQUE (NON-COLORED) MICROSPHERES (February 24, 2014)
  • K132675 — EMBOZENE MICROSPHERES (October 3, 2013)
  • K130307 — ONCOZENE MICROSPHERES 40UM, 2ML, ONCOZENE MICROSPHERES 75UM, 2ML, ONCOZENE MICRO (March 4, 2013)
  • K073417 — EMBOZENE MICROSPHERES (December 15, 2008)

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