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510(k) K041835

ENDOTINE MIDFACE B 4.5 DEVICE by Coapt Systems, Inc. — Product Code HWC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 28, 2004
Date Received
July 7, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Screw, Fixation, Bone
Device Class
Class II
Regulation Number
888.3040
Review Panel
OR
Submission Type

Other clearances by Coapt Systems, Inc.

  • K083783 — VF LIQUIGEL (September 11, 2009)
  • K080956 — MODIFICATION TO VF GEL PLUS (April 25, 2008)
  • K071663 — VF GEL PLUS (February 15, 2008)
  • K060249 — ULTRATINE FOREHEAD (June 12, 2006)
  • K060248 — ULTRATINE TRANSBLEPH (June 12, 2006)
  • K060828 — MODIFICATION TO ENDOTINE RIBBON (April 19, 2006)
  • K051415 — ENDOTINE RIBBON (June 23, 2005)
  • K050611 — ENDOTINE RIBBON (April 6, 2005)
  • K042796 — ENDOTINE TRANSBLEPH 3.0/3.5 DEVICE (November 5, 2004)
  • K042078 — ENDOTINE FOREHEAD TRIPLE DEVICE (August 27, 2004)

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