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510(k) K011848

CIRCON AEH-4 ELECTROHYDRAULIC LITHOTRIPSY PROBE by Circon Video — Product Code FFK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 11, 2001
Date Received
June 13, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lithotriptor, Electro-Hydraulic
Device Class
Class II
Regulation Number
876.4480
Review Panel
GU
Submission Type

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