UNIMED SUCTION-IRRIGATION ELECTRODE AND SLIDING SHEATH

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 Unimed Suction-irrigation Electrode And Sliding Sheath.

Pre-market Notification Details

Device IDK963338
510k NumberK963338
Device Name:UNIMED SUCTION-IRRIGATION ELECTRODE AND SLIDING SHEATH
ClassificationElectrosurgical, Cutting & Coagulation & Accessories
Applicant UNIMED SURGICAL PRODUCTS, INC. 10401 BELCHER RD. Largo,  FL  33777
ContactRonald R Froemming
CorrespondentRonald R Froemming
UNIMED SURGICAL PRODUCTS, INC. 10401 BELCHER RD. Largo,  FL  33777
Product CodeGEI  
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-08-23
Decision Date1996-10-21
Summary:summary

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