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510(k) K902320

BAUER FLEXI-TEMNO BIOPSY NEEDLE by Proact, Ltd. — Product Code FCG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 1, 1990
Date Received
May 23, 1990
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 Proact, Ltd.

  • K052243 — PROACT WITH GEL OR PROACT 1 (April 12, 2006)
  • K003909 — PROACT 1 (June 13, 2001)
  • K941256 — QUICK CORE II (July 13, 1994)
  • K926559 — PROACT BIOPSY NEEDLE ENCHANCEMENTS (March 22, 1993)
  • K913306 — BONE-TEMNO/STERNUM-TEMNO (November 1, 1991)
  • K902319 — BAUER TEMNO BIOPSY NEEDLE (September 6, 1990)

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