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510(k) K051415

ENDOTINE RIBBON by Coapt Systems, Inc. — Product Code GAM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 23, 2005
Date Received
June 1, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Suture, Absorbable, Synthetic, Polyglycolic Acid
Device Class
Class II
Regulation Number
878.4493
Review Panel
SU
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)
  • K060248 — ULTRATINE TRANSBLEPH (June 12, 2006)
  • K060249 — ULTRATINE FOREHEAD (June 12, 2006)
  • K060828 — MODIFICATION TO ENDOTINE RIBBON (April 19, 2006)
  • 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)
  • K042078 — ENDOTINE FOREHEAD TRIPLE DEVICE (August 27, 2004)

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