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510(k) K924271

CHIBA/FRANSEEN/WESTCOTT/SPINAL STYLE NEEDLES by Core Medical, Inc. — Product Code FCG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 23, 1992
Date Received
August 24, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Biopsy Needle
Device Class
Class II
Regulation Number
876.1075
Review Panel
GU
Submission Type

Other clearances by Core Medical, Inc.

  • K924270 — BREAST LESION LOCALIZATION NEEDLE (September 23, 1992)
  • K914732 — CORE MEDICAL BIOPSY NEEDLE (January 7, 1992)

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