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510(k) K990341

ELECTRO MECHANICAL LITHOTRIPTOR by Northgate Technologies, Inc. — Product Code FFK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 14, 1999
Date Received
February 3, 1999
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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  • K132795 — CYBERWAND STERILE PROBE SET (November 26, 2013)
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