SURGI-LINK LLETZ NEEDLE ELECTRODE, LOOP ELECTRODE, SQUARE LOOP ELECTRODE

Electrocautery, Gynecologic (and Accessories)

UNIMED SURGICAL PRODUCTS, INC.

The following data is part of a premarket notification filed by Unimed Surgical Products, Inc. with the FDA for Surgi-link Lletz Needle Electrode, Loop Electrode, Square Loop Electrode.

Pre-market Notification Details

Device IDK944450
510k NumberK944450
Device Name:SURGI-LINK LLETZ NEEDLE ELECTRODE, LOOP ELECTRODE, SQUARE LOOP ELECTRODE
ClassificationElectrocautery, Gynecologic (and Accessories)
Applicant UNIMED SURGICAL PRODUCTS, INC. 10401 BELCHER RD. Largo,  FL  34647
ContactLorna K Linville
CorrespondentLorna K Linville
UNIMED SURGICAL PRODUCTS, INC. 10401 BELCHER RD. Largo,  FL  34647
Product CodeHGI  
CFR Regulation Number884.4120 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-09-12
Decision Date1995-07-25

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