NEEDLE ELCTRODE

Electrosurgical, Cutting & Coagulation & Accessories

UNIMED SURGICAL PRODUCTS, INC.

The following data is part of a premarket notification filed by Unimed Surgical Products, Inc. with the FDA for Needle Elctrode.

Pre-market Notification Details

Device IDK944265
510k NumberK944265
Device Name:NEEDLE ELCTRODE
ClassificationElectrosurgical, Cutting & Coagulation & 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 CodeGEI  
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-09-01
Decision Date1995-05-05

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
50749756325900 K944265 000

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