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510(k) K010735

SPEEDYBELL by Biopsybell S.A.S. — Product Code KNW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 17, 2001
Date Received
March 12, 2001
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

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  • K180315 — DISKOM (March 26, 2018)
  • K130616 — MANUAL-BONE-MARROW-BIOPSY-NEEDLES, SEMI-AUTOMATIC-BIOPSY-NEEDLES, AUTOMATIC-BIOP (February 7, 2014)
  • K011075 — EASYBELL (June 27, 2001)
  • K011104 — OSTEOBELL (May 31, 2001)

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