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510(k) K170305

Spinal Manometer NRFit; Spinal Manometer LUER by PAJUNK GmbH Medizintechnologie — Product Code FMJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 25, 2017
Date Received
January 31, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Manometer, Spinal-Fluid
Device Class
Class II
Regulation Number
880.2500
Review Panel
HO
Submission Type

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Other clearances for product code FMJ

  • K032432 — BUSSE HOSPITAL DISPOSABLES SPINAL MANOMETER (August 28, 2003)
  • K970287 — LUMBAR PUNCTURE KIT (April 7, 1997)
  • K963570 — SIMS ADULT LUMBAR PUNCTURE KIT (4800-20,4801-20,4806-22,4807-22) (October 18, 1996)
  • K910089 — MEGA LUMBAR PUNCTURE KIT (June 20, 1991)
  • K882405 — HYPODERMIC NEEDLE SHEATH HOLDER (June 29, 1988)