LOOP RETRIEVER

Dislodger, Stone, Basket, Ureteral, Metal

ANNEX MEDICAL, INC.

The following data is part of a premarket notification filed by Annex Medical, Inc. with the FDA for Loop Retriever.

Pre-market Notification Details

Device IDK910603
510k NumberK910603
Device Name:LOOP RETRIEVER
ClassificationDislodger, Stone, Basket, Ureteral, Metal
Applicant ANNEX MEDICAL, INC. 7887 FULLER RD. #109 Eden Prairie,  MN  55344
ContactStuart J Lind
CorrespondentStuart J Lind
ANNEX MEDICAL, INC. 7887 FULLER RD. #109 Eden Prairie,  MN  55344
Product CodeFFL  
CFR Regulation Number876.4680 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-02-12
Decision Date1991-03-11

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