OLSEN MEDICAL INTEGRATED IRRIGATION TUBING AND BIPOLAR CORD SET

Electrosurgical, Cutting & Coagulation & Accessories

OLSEN MEDICAL

The following data is part of a premarket notification filed by Olsen Medical with the FDA for Olsen Medical Integrated Irrigation Tubing And Bipolar Cord Set.

Pre-market Notification Details

Device IDK072937
510k NumberK072937
Device Name:OLSEN MEDICAL INTEGRATED IRRIGATION TUBING AND BIPOLAR CORD SET
ClassificationElectrosurgical, Cutting & Coagulation & Accessories
Applicant OLSEN MEDICAL 3001 WEST KENTUCKY ST. Louisville,  KY  40211
ContactJohn P Waters
CorrespondentJohn P Waters
OLSEN MEDICAL 3001 WEST KENTUCKY ST. Louisville,  KY  40211
Product CodeGEI  
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-10-16
Decision Date2007-12-28
Summary:summary

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