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510(k) K023643

MACROPORE SURGICAL BARRIER FILM by Macropore Biosurgery, Inc. — Product Code MTZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 21, 2003
Date Received
October 30, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Wrap, Implant, Orbital
Device Class
Class II
Regulation Number
886.3320
Review Panel
OP
Submission Type

Other clearances by Macropore Biosurgery, Inc.

  • K042261 — MACROPORE PURICEL LIPOPLASTY SYSTEM (September 20, 2004)
  • K041105 — MACROPORE HYDROSORB SPINE SYSTEM (July 28, 2004)
  • K031955 — MACROPORE SURGI-WRAP MAST BIORESORBABLE SHEET (September 22, 2003)
  • K031785 — MACROPORE CARDIO-WRAP (TS) (September 4, 2003)
  • K024169 — MACROPORE OS RECONSTRUCTION (July 1, 2003)
  • K021164 — MACROPORE OS TRAUMA (July 1, 2002)
  • K012025 — MACROPORE SURGIWRAP (TS) (December 3, 2001)
  • K012769 — MACROPORE ENT RECONSTRUCTION FILM (October 25, 2001)
  • K012413 — MACROPORE FX, PS, NS, LP (September 18, 2001)
  • K011715 — MACROPORE IB RESORBABLE PLUG (August 27, 2001)

Other clearances for product code MTZ

  • K973552 — OCU-GUARD ORBITAL IMPLANT WRAP, SUPPLE OCU-GUARD ORBITAL IMPLANT WRAP (December 16, 1997)