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510(k) K023089

GELSPHERES EMBOLIC AGENT by Biocure, Inc. — Product Code HCG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 16, 2002
Date Received
September 17, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Neurovascular Embolization
Device Class
Class II
Regulation Number
882.5950
Review Panel
NE
Submission Type

Other clearances by Biocure, Inc.

  • K073663 — GELSPRAY WOUND DRESSING (January 30, 2008)

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