ENDOSCOPIC ACCESSORY

Electrode, Electrosurgical, Active, Urological

UN-I-MED, INC.

The following data is part of a premarket notification filed by Un-i-med, Inc. with the FDA for Endoscopic Accessory.

Pre-market Notification Details

Device IDK945191
510k NumberK945191
Device Name:ENDOSCOPIC ACCESSORY
ClassificationElectrode, Electrosurgical, Active, Urological
Applicant UN-I-MED, INC. 10401 BELCHER RD. Largo,  FL  34647
ContactLorna K Linville
CorrespondentLorna K Linville
UN-I-MED, INC. 10401 BELCHER RD. Largo,  FL  34647
Product CodeFAS  
CFR Regulation Number876.4300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-10-24
Decision Date1995-05-03

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