WILTEK BALLOON STONE EXTRACTOR

Dislodger, Stone, Biliary

WILTEK MEDICAL, INC.

The following data is part of a premarket notification filed by Wiltek Medical, Inc. with the FDA for Wiltek Balloon Stone Extractor.

Pre-market Notification Details

Device IDK894865
510k NumberK894865
Device Name:WILTEK BALLOON STONE EXTRACTOR
ClassificationDislodger, Stone, Biliary
Applicant WILTEK MEDICAL, INC. P.O.BOX 11946 Winston-salem,  NC  27116
ContactJon S Wilson
CorrespondentJon S Wilson
WILTEK MEDICAL, INC. P.O.BOX 11946 Winston-salem,  NC  27116
Product CodeLQR  
CFR Regulation Number876.5010 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-07-31
Decision Date1989-12-21

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