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510(k) K021397

EMBOSPHERE MICROSPHERES AND EMBOGOLD MICROSPHERES FOR USE IN UTERINE FIBROID EMBOLIZATION by Biosphere Medical, Inc. — Product Code NAJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 22, 2002
Date Received
May 2, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Agents, Embolic, For Treatment Of Uterine Fibroids
Device Class
Class II
Regulation Number
870.3300
Review Panel
OB
Submission Type

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Other clearances for product code NAJ

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  • K130259 — BEARING NSPVA EMBOLIZATION PARTICLES (June 7, 2013)
  • K100663 — CONTOUR EMBOLIZATION PARTICLES, MODELS M0017600121, M0017600221, M0017600321 (April 16, 2010)
  • K081768 — COOK INCORPORATED POLYVINYL ALCOHOL FOAM EMBOLIZATION PARTICLES (December 23, 2008)
  • K030966 — CONTOUR EMBOLI PVA AND FASTRACKER-325 INFUSION CATHETER (September 23, 2003)