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510(k) K073391

SURGISIS BIODESIGN TISSUE GRAFT by Cook Biotech, Inc. — Product Code FTM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 21, 2008
Date Received
December 3, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mesh, Surgical
Device Class
Class II
Regulation Number
878.3300
Review Panel
SU
Submission Type

Other clearances by Cook Biotech, Inc.

  • K133306 — SIS HERNIA GRAFT (July 23, 2014)
  • K133011 — DIAPHRAGMATIC HERNIA GRAFT (June 20, 2014)
  • K131015 — BIODESIGN ONLAY DURAL GRAFT OR BIODESIGN DURAPLASTY GRAFT (October 8, 2013)
  • K111695 — HYBRID GRAFT (April 2, 2012)
  • K110402 — BIODESIGN NIPPLE RECONSTRUCTION CYLINDER (June 20, 2011)
  • K090688 — COOK UROLOGICAL GRAFT (July 10, 2009)
  • K082682 — SURGISIS BIODESIGN ENTEROCUTANEOUS FISTULA PLUG (February 27, 2009)
  • K082058 — DYNAMATRIX (October 2, 2008)
  • K070405 — MODIFICATION TO SURGISIS SLR STAPLE LINE REINFORCEMENT (October 17, 2007)
  • K070738 — SIS FACIAL CYLINDER, SIS FACIAL IMPLANT (April 5, 2007)

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