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510(k) K973552

OCU-GUARD ORBITAL IMPLANT WRAP, SUPPLE OCU-GUARD ORBITAL IMPLANT WRAP by Bio-Vascular, Inc. — Product Code MTZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 16, 1997
Date Received
September 19, 1997
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 Bio-Vascular, Inc.

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  • K992537 — PERI-STRIPS-SLEEVE, PERI-STRIPS-STRIP AND PERI-STRIPS DRY (NON-NAOH-TREATED AND (February 22, 2000)
  • K983602 — CV PERI-GUARD AND VASCU-GUARD (November 12, 1998)
  • K983581 — OCU-GUARD AND OCU-GUARD SUPPLE (November 6, 1998)
  • K983162 — PERI-GUARD, CV PERI-GUARD, OCU-GUARD, SUPPLE PERI-GUARD, PERI-STRIPS - SLEEVE, P (October 9, 1998)
  • K981624 — FLO-THRU (August 4, 1998)
  • K982282 — DURA-GUARD - DURAL REPAIR PATCH (July 30, 1998)
  • K971726 — CV PERI-GUARD - CARDIOVASCULAR PATCH (April 10, 1998)
  • K973706 — DURA-GUARD-DURAL REPAIR PATCH (December 24, 1997)
  • K971048 — PERI-STRIPS DRY - STAPLE LINE REINFORCEMENT (May 9, 1997)

Other clearances for product code MTZ

  • K023643 — MACROPORE SURGICAL BARRIER FILM (February 21, 2003)