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510(k) K990100

POLYMEDIC UPA NERVE STIMULATION NEEDLE; POLYMEDIC UPC NERVE STIMULATION NEEDLE by Te ME NA S.A.R.L. — Product Code GXZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 2, 2000
Date Received
January 4, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrode, Needle
Device Class
Class II
Regulation Number
882.1350
Review Panel
NE
Submission Type

Other clearances by Te ME NA S.A.R.L.

  • K990323 — TE ME NA POLYSTIM NERVE STIMILATOR (September 28, 2001)
  • K002405 — SPINAL EPIDURAL NEEDLES (June 1, 2001)
  • K991259 — TE ME NA EPIDURAL CATHETER (February 21, 2001)
  • K990020 — TE ME NA LOSS OF RESISTANCE SYRINGE, 10CC (June 24, 1999)

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