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510(k) K981624

FLO-THRU by Bio-Vascular, Inc. — Product Code DXC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 4, 1998
Date Received
May 7, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Clamp, Vascular
Device Class
Class II
Regulation Number
870.4450
Review Panel
CV
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)
  • 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)
  • K973552 — OCU-GUARD ORBITAL IMPLANT WRAP, SUPPLE OCU-GUARD ORBITAL IMPLANT WRAP (December 16, 1997)
  • K971048 — PERI-STRIPS DRY - STAPLE LINE REINFORCEMENT (May 9, 1997)

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