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510(k) K931464

BAXTER CORONARY ANGIOSCOPE INFLATION DEVICE by Baxter Healthcare Corp — Product Code LYK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 18, 1993
Date Received
March 24, 1993
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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