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510(k) K060828

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 19, 2006
Date Received
March 27, 2006
Clearance Type
Special
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)
  • 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)
  • K042078 — ENDOTINE FOREHEAD TRIPLE DEVICE (August 27, 2004)

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