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510(k) K024089

VACUFLASH BIOPSY SYSTEM by Bip USA, Inc. — Product Code KNW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 11, 2003
Date Received
December 11, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Biopsy
Device Class
Class II
Regulation Number
876.1075
Review Panel
SU
Submission Type

Other clearances by Bip USA, Inc.

  • K934371 — BIP MULTI MODIFICATION (April 28, 1994)
  • K934370 — BIP BIOPSY NEEDLE MODIFICATION (March 7, 1994)
  • K935457 — LOCALIZATION WIRE OR MARKER - SURGICAL (February 17, 1994)
  • K925870 — SPACER (May 19, 1993)
  • K925875 — HORIZONTAL NEEDLE GUIDE ATTACHMENT (April 6, 1993)
  • K925874 — BREAST STABILIZER (March 16, 1993)

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