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510(k) K203397

Marrow-Pack (white)- 11gauge/10cm or 13gauge/10cm, Marrow-Tray (red)- 11gauge/10cm or 13gauge/10cm, Marrow-Set (violet)- 11gauge/10cm or 13gauge/10cm, Marrow-kit (grey)- 11gauge/10cm or 13gauge/10cm, Marrow-Stem (green)- 11gauge/10cm or 13gauge/10cm by Biopsybell S.R.L. — Product Code KNW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 11, 2021
Date Received
November 18, 2020
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 Biopsybell S.R.L.

  • K231340 — Renova Spine Balloon Catheter (October 30, 2023)
  • K180315 — DISKOM (March 26, 2018)
  • K130616 — MANUAL-BONE-MARROW-BIOPSY-NEEDLES, SEMI-AUTOMATIC-BIOPSY-NEEDLES, AUTOMATIC-BIOP (February 7, 2014)
  • K010735 — SPEEDYBELL (August 17, 2001)
  • K011075 — EASYBELL (June 27, 2001)
  • K011104 — OSTEOBELL (May 31, 2001)

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