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510(k) K111436

PORCINE SURGICAL MESH, PORCINE DERMAL MATRIX by Brennen Medical, LLC — Product Code FTM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 14, 2011
Date Received
May 24, 2011
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 Brennen Medical, LLC

  • K113866 — PORCINE DERMAL XENOGRAFTS PORCINE DERMAL MATRIX (March 23, 2012)
  • K081272 — PORCINE SURGICAL MESH; DERMAL MATRIX (July 31, 2008)
  • K050086 — BRENNEN MEDICAL SILVER GLUCAN WOUND DRESSING (February 17, 2006)
  • K030460 — MODIFICATION TO BRENNEN BIOSYNTHETIC SURGICAL MESH MATRIX (March 7, 2003)
  • K021835 — BRENNEN MEDICAL SURGICAL MESH, GLUCAMESH/GLUCATEX (October 17, 2002)
  • K002078 — BETA GLUCAN GEL (MACROPRO GEL) (October 2, 2000)
  • K002077 — GLUCANPRO CREAM (October 2, 2000)
  • K000518 — MACROPRO GEL (May 1, 2000)
  • K000519 — GLUCANPRO (May 1, 2000)
  • K982825 — BRENNEN MEDICAL BETA GLUCAN GEL (November 6, 1998)

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