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510(k) K910089

MEGA LUMBAR PUNCTURE KIT by Megadyne Medical Products, Inc. — Product Code FMJ

Clearance Details

Decision
SESK (Substantially Equivalent (kit))
Decision Date
June 20, 1991
Date Received
January 9, 1991
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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  • K080741 — MEGA SOFT REUSABLE PATIENT RETURN ELECTRODE (December 16, 2008)
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Other clearances for product code FMJ

  • K170305 — Spinal Manometer NRFit; Spinal Manometer LUER (July 25, 2017)
  • 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)
  • K882405 — HYPODERMIC NEEDLE SHEATH HOLDER (June 29, 1988)