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510(k) K041344

OPEN BORE SYRINGE by Isotis NV — Product Code FMF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 16, 2004
Date Received
May 20, 2004
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Syringe, Piston
Device Class
Class II
Regulation Number
880.5860
Review Panel
HO
Submission Type

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  • K031813 — OSSATURA DENTAL (August 20, 2004)
  • K030131 — OSSATURA BCP BONE VOID FILLER (May 20, 2003)
  • K010840 — SYNPLUG (April 20, 2001)
  • K000587 — SHUTTLE STOP (May 4, 2000)

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