BITX PROBES

Electrosurgical, Cutting & Coagulation & Accessories

EVEREST MEDICAL CORP.

The following data is part of a premarket notification filed by Everest Medical Corp. with the FDA for Bitx Probes.

Pre-market Notification Details

Device IDK993412
510k NumberK993412
Device Name:BITX PROBES
ClassificationElectrosurgical, Cutting & Coagulation & Accessories
Applicant EVEREST MEDICAL CORP. 13755 FIRST AVENUE, NORTH, SUITE 500 Minneapolis,  MN  55441 -5444
ContactFrederick G Mades
CorrespondentFrederick G Mades
EVEREST MEDICAL CORP. 13755 FIRST AVENUE, NORTH, SUITE 500 Minneapolis,  MN  55441 -5444
Product CodeGEI  
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-10-12
Decision Date2000-03-31
Summary:summary

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