SINGLE USE BALL ELECTRODE

Electrosurgical, Cutting & Coagulation & Accessories

ASPEN LABORATORIES, INC.

The following data is part of a premarket notification filed by Aspen Laboratories, Inc. with the FDA for Single Use Ball Electrode.

Pre-market Notification Details

Device IDK780976
510k NumberK780976
Device Name:SINGLE USE BALL ELECTRODE
ClassificationElectrosurgical, Cutting & Coagulation & Accessories
Applicant ASPEN LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeGEI  
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1978-06-09
Decision Date1978-06-22

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