STONE BASKET

Dislodger, Stone, Basket, Ureteral, Metal

SURGITEK MEDICAL ENGINEERING CORP.

The following data is part of a premarket notification filed by Surgitek Medical Engineering Corp. with the FDA for Stone Basket.

Pre-market Notification Details

Device IDK914505
510k NumberK914505
Device Name:STONE BASKET
ClassificationDislodger, Stone, Basket, Ureteral, Metal
Applicant SURGITEK MEDICAL ENGINEERING CORP. 3037 MT. PLEASANT ST. Racine,  WI  53404
ContactBrian Kunst
CorrespondentBrian Kunst
SURGITEK MEDICAL ENGINEERING CORP. 3037 MT. PLEASANT ST. Racine,  WI  53404
Product CodeFFL  
CFR Regulation Number876.4680 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-10-09
Decision Date1991-12-09

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