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510(k) K013231

AVID-NIT PLASTIC HUB LUTZ EPIDURAL NEEDLE,MODEL RP2035L, AVID-NIT METAL HUB LUTZ EPIDURAL NEEDLE, MODEL RM2035L by Avid N.I.T., Inc. — Product Code BSP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 3, 2001
Date Received
September 27, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Needle, Conduction, Anesthetic (W/Wo Introducer)
Device Class
Class II
Regulation Number
868.5150
Review Panel
AN
Submission Type

Other clearances by Avid N.I.T., Inc.

  • K014246 — AVID-NIT NERVE STIMULATION NEEDLES (July 16, 2002)
  • K983218 — N,I.T., INC. AUTOMATIC CUTTING BIOPSY NEEDLE (November 6, 1998)
  • K972595 — ALDRETE EPIDURAL NEEDLE WITHOUT INTRODUCER (May 20, 1998)
  • K972554 — REGANES RADIONUCLIDE SEED MAGAZINE (February 17, 1998)
  • K973037 — N.I.T., INC. RADIONUCLIDE SEED APPLICATOR, MODEL SA-1000 (January 27, 1998)
  • K973638 — N.I.T., INC. NEEDLE GUIDING TEMPLATE (December 23, 1997)
  • K971645 — REGANES SPINAL NEEDLE (VARIOUS) (August 1, 1997)
  • K945965 — ATRAUMATIC PENCIL POINT SPINAL NEEDLE (August 2, 1995)

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