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510(k) K113209

CHIBA SONO by Pajunk GmbH — Product Code KNW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 21, 2011
Date Received
October 31, 2011
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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  • K042979 — MODIFICATION TO: PLEXALONG SETS (December 21, 2004)
  • K043130 — MODIFICATION TO PAJUNK STIMULONG PLUS CATHETER SETS (December 21, 2004)
  • K040965 — PAJUNK TUOHY NEEDLES, QUINCKE NEEDLES, CHIBA NEEDLES & CRAWFORD NEEDLES (September 7, 2004)
  • K033018 — STIMULONG PLUS CATHETER SET MODEL, VARIOUS (May 5, 2004)
  • K033249 — PAJUNK MODULAR HANDLE INSTRUMENTS (March 5, 2004)
  • K023218 — MODIFICATION TO PLEXOLONG SETS (March 24, 2003)

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