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510(k) K990020

TE ME NA LOSS OF RESISTANCE SYRINGE, 10CC by Te ME NA S.A.R.L. — Product Code FMF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 24, 1999
Date Received
January 4, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Syringe, Piston
Device Class
Class II
Regulation Number
880.5860
Review Panel
HO
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)
  • K990100 — POLYMEDIC UPA NERVE STIMULATION NEEDLE; POLYMEDIC UPC NERVE STIMULATION NEEDLE (August 2, 2000)

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