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510(k) K881449

EDWARDS-DUROMEDICS LEAFLET PROBE, MODEL 1116 by Baxter Healthcare Corp — Product Code LXN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 15, 1988
Date Received
April 5, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Probe, Test, Heart-Valve
Device Class
Class I
Regulation Number
870.4500
Review Panel
CV
Submission Type

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Other clearances for product code LXN

  • K890165 — FORCEPS-ORTHOPEDIC (February 13, 1989)