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510(k) K943191

MICROVASIVE(R) MONOLITH(TM) MECHANICAL LITHOTRIPTOR by Boston Scientific Corp — Product Code LQC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 29, 1994
Date Received
July 5, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lithotriptor, Biliary Mechanical
Device Class
Class II
Regulation Number
876.4500
Review Panel
GU
Submission Type

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