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510(k) K150563

Marrow Cellution Bone Marrow Aspiration Needle by Ranfac, Corp. — Product Code KNW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 22, 2015
Date Received
March 6, 2015
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 Ranfac, Corp.

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  • K140991 — RANFAC ASPIRATION NEEDLE WITH ADJUSTABLE GUIDE (September 11, 2014)
  • K131157 — RANFAC BONE MARROW ASPIRATION NEEDLE (October 22, 2013)
  • K031344 — RANFAC GOLDENBERG SNARECOIL SOFT TISSUE BIOPSY (GSS) NEEDLE (May 23, 2003)
  • K012224 — SINGLE ACTION BIOPSY NEEDLE, MODEL RCBS: XX GAUGE, XX LENGTH, XX THROW (August 22, 2001)
  • K961922 — RDP-2 (August 9, 1996)
  • K951090 — INTRODUCER (July 11, 1995)
  • K930474 — NEEDLE, PNEUMOPERITONEUM, SPRING LOADED (July 23, 1993)
  • K864139 — RANFAC CUT BIOPSY NEEDLE (November 5, 1986)

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