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510(k) K032432

BUSSE HOSPITAL DISPOSABLES SPINAL MANOMETER by Busse Hospital Disposables, Inc. — Product Code FMJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 28, 2003
Date Received
August 6, 2003
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

Other clearances by Busse Hospital Disposables, Inc.

  • K141285 — BUSSE EXTENSION SET (February 19, 2015)
  • K120002 — I-STYLE BONE MARROW ASPIRATION NEEDLE WITH T-HANDLE (June 26, 2012)
  • K110883 — J-STYLE BONE MARROW BIOPSY / ASPIRATION NEEDLE WITH SNARE-IT MARROW ACQUISITION (June 8, 2011)
  • K093920 — BUSSE EPIDURAL CATHETER KIT (August 6, 2010)
  • K093909 — BUSSE SURGICAL DRAPES IV (May 6, 2010)
  • K092212 — BUSSE SURGICAL DRAPES III (October 9, 2009)
  • K082297 — BUSSE SURGICAL DRAPE (December 9, 2008)
  • K073222 — MODIFICATION TO:SPECIALTY NEEDLES (April 9, 2008)
  • K070465 — BUSSE EPIDURAL CATHETER (July 19, 2007)
  • K063018 — GLASS LOSS OF RESISTANCE SYRINGE (January 22, 2007)

Other clearances for product code FMJ

  • K170305 — Spinal Manometer NRFit; Spinal Manometer LUER (July 25, 2017)
  • 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)