HATCHER STONE-EMBOLIS EXTRACTOR

Dislodger, Stone, Biliary

IDEAL MEDICAL, INC.

The following data is part of a premarket notification filed by Ideal Medical, Inc. with the FDA for Hatcher Stone-embolis Extractor.

Pre-market Notification Details

Device IDK931115
510k NumberK931115
Device Name:HATCHER STONE-EMBOLIS EXTRACTOR
ClassificationDislodger, Stone, Biliary
Applicant IDEAL MEDICAL, INC. 12167 49TH ST. NORTH P.O. BOX 17327 Clearwater,  FL  34622
ContactLorna K Linville
CorrespondentLorna K Linville
IDEAL MEDICAL, INC. 12167 49TH ST. NORTH P.O. BOX 17327 Clearwater,  FL  34622
Product CodeLQR  
CFR Regulation Number876.5010 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-03-04
Decision Date1993-08-20

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