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510(k) K965137

FOGARTY VALVULOTOME MODEL 700091 by Baxter Edwards — Product Code MGZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 4, 1997
Date Received
December 23, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Valvulotome
Device Class
Class II
Regulation Number
870.4885
Review Panel
CV
Submission Type

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  • K080178 — VALVULOTOME BY KOVEN (July 28, 2008)
  • K022823 — VALVULOTOME, RETROGRADE : 03-7500- 03-7510, ANTEGRADE 03-7520 (July 1, 2004)