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510(k) K902329

ULTRA-VU ANGIOSCOPE by Angiolaz, Inc. — Product Code LYK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 22, 1990
Date Received
May 24, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Angioscope
Device Class
Class II
Regulation Number
876.1500
Review Panel
CV
Submission Type

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  • K933868 — ANGIOLAZ VIDEO ENDOSCOPIC SYSTEM MODEL CAMLUM1 AND ACCESSORIES (November 10, 1993)
  • K913129 — ANGIOLAZ ANGIOSCOPE CATHETER (December 27, 1991)

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