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510(k) K072432

F3 FRACTURED FINGER FIXATOR, STERILE (MODEL: FCS 400) AND NON STERILE by Hand Biomechanics Lab, Inc. — Product Code JEC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 9, 2008
Date Received
August 29, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Component, Traction, Invasive
Device Class
Class II
Regulation Number
888.3040
Review Panel
OR
Submission Type

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  • K082679 — LAKI HAND FIXATION SYSTEM, MODEL TFX.3X.06.X (April 7, 2009)
  • K071476 — SYNTHES (USA) 2ND GENERATION PELVIC C-CLAMP (August 24, 2007)