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510(k) K014153

COAPT SYSTMES ENDOTINE DEVICE by Coapt Systems, Inc. — Product Code HWC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 15, 2002
Date Received
December 18, 2001
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.

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  • K080956 — MODIFICATION TO VF GEL PLUS (April 25, 2008)
  • K071663 — VF GEL PLUS (February 15, 2008)
  • K060248 — ULTRATINE TRANSBLEPH (June 12, 2006)
  • K060249 — ULTRATINE FOREHEAD (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)
  • K041835 — ENDOTINE MIDFACE B 4.5 DEVICE (September 28, 2004)

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