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510(k) K850394

LEMAITRE RETROGRADE VALVULOTOME-MANU-SURGICA INSTR by Vascutech, Inc. — Product Code DWS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 24, 1985
Date Received
February 1, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instruments, Surgical, Cardiovascular
Device Class
Class I
Regulation Number
870.4500
Review Panel
CV
Submission Type

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