STONE RETRIEVAL BASKET

Dislodger, Stone, Basket, Ureteral, Metal

ENDOMEDIX

The following data is part of a premarket notification filed by Endomedix with the FDA for Stone Retrieval Basket.

Pre-market Notification Details

Device IDK930349
510k NumberK930349
Device Name:STONE RETRIEVAL BASKET
ClassificationDislodger, Stone, Basket, Ureteral, Metal
Applicant ENDOMEDIX 2162 MICHELSON DR. Irvine,  CA  92715 -1304
ContactLeigh Weintraub
CorrespondentLeigh Weintraub
ENDOMEDIX 2162 MICHELSON DR. Irvine,  CA  92715 -1304
Product CodeFFL  
CFR Regulation Number876.4680 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-01-25
Decision Date1993-06-09

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