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510(k) K120002

I-STYLE BONE MARROW ASPIRATION NEEDLE WITH T-HANDLE by Busse Hospital Disposables, Inc. — Product Code KNW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 26, 2012
Date Received
January 3, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Biopsy
Device Class
Class II
Regulation Number
876.1075
Review Panel
SU
Submission Type

Other clearances by Busse Hospital Disposables, Inc.

  • K141285 — BUSSE EXTENSION SET (February 19, 2015)
  • 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)
  • K061394 — SPECIALTY NEEDLES (SPINAL NEEDLE, PENCIL POINT SPINAL NEEDLE, EPIDURAL NEEDLE) (September 6, 2006)

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