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510(k) K011206

PARALLAX BONE AND VERTEBRAL BODY BIOPSY AND INFUSION NEEDLES by Parallax Medical, Inc. — Product Code KNW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 18, 2001
Date Received
April 19, 2001
Clearance Type
Abbreviated
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 Parallax Medical, Inc.

  • K033230 — TRACERS TA BONE CEMENT OPACIFIER, MODEL TCR-TA (December 12, 2003)
  • K023445 — TRACERS BONE CEMENT OPACIFIER (March 11, 2003)
  • K022169 — CLEARVIEW PLUS BONE AND VERTEBRAL BODY BIOPSY NEEDLES (July 25, 2002)
  • K994022 — PARALLAX CRANIOSET (August 31, 2000)
  • K991893 — PARALLAX TRACER RADIOPAQUE PARTICLES (August 13, 1999)

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