CYBERWAND STERILE PADS, MODEL: CW-RBPBX

Lithotriptor, Electro-hydraulic

CYBERSONICS, INC.

The following data is part of a premarket notification filed by Cybersonics, Inc. with the FDA for Cyberwand Sterile Pads, Model: Cw-rbpbx.

Pre-market Notification Details

Device IDK072422
510k NumberK072422
Device Name:CYBERWAND STERILE PADS, MODEL: CW-RBPBX
ClassificationLithotriptor, Electro-hydraulic
Applicant CYBERSONICS, INC. 5368 KUHL RD. Erie,  PA  16510 -4703
ContactWilliam A Stoll
CorrespondentWilliam A Stoll
CYBERSONICS, INC. 5368 KUHL RD. Erie,  PA  16510 -4703
Product CodeFFK  
CFR Regulation Number876.4480 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-08-28
Decision Date2007-10-24

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