ELECTROSURGICAL FLEXIBLE ELECTRODE IN-LINE SUCTION COAGULATOR

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 Electrosurgical Flexible Electrode In-line Suction Coagulator.

Pre-market Notification Details

Device IDK944012
510k NumberK944012
Device Name:ELECTROSURGICAL FLEXIBLE ELECTRODE IN-LINE SUCTION COAGULATOR
ClassificationElectrosurgical, Cutting & Coagulation & Accessories
Applicant ASPEN LABORATORIES, INC. 14603 E. FREMONT AVE. Englewood,  CO  80112
ContactCharles M Hart
CorrespondentCharles M Hart
ASPEN LABORATORIES, INC. 14603 E. FREMONT AVE. Englewood,  CO  80112
Product CodeGEI  
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-08-16
Decision Date1994-12-21

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