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510(k) K960065

TEMNO DOUBLE SHOT BIOPSY NEEDLE by Bauer Medical, Inc. — Product Code KNW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 5, 1996
Date Received
January 5, 1996
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 Bauer Medical, Inc.

  • K960064 — TEMNO ACHIEVE BIOPSY NEEDLE (April 5, 1996)
  • K935538 — BAUER TEMNO COAXIAL NEEDLE (February 22, 1994)

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