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510(k) K951598

PRO-B BIOPSY NEEDLE by Promedical , Ltd. — Product Code FCG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 21, 1995
Date Received
April 7, 1995
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 Promedical , Ltd.

  • K954596 — PRO-B CORE-RECT COAXIAL BIOPSY SYSTEM (October 7, 1995)
  • K952350 — JAMSHIDI STYLE BIOPSY NEEDLE (ACRI) (BIOMID), ILLINOIS STYLE BIOPSY NEEDLE (ISAN (July 17, 1995)
  • K944944 — CHIBA, FRANSEEN, WESTCOTT, SPINAL STYLE ASPIRATION BIOPSY NEEDLE (December 21, 1994)
  • K944942 — BREAST LESION LOCALIZATION NEEDLE (November 4, 1994)

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