ELECTROSURGICAL UNIT-MF 380 #60-1700

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 Unit-mf 380 #60-1700.

Pre-market Notification Details

Device IDK831291
510k NumberK831291
Device Name:ELECTROSURGICAL UNIT-MF 380 #60-1700
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 Received1983-04-20
Decision Date1983-06-02

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
30653405043946 K831291 000
30653405009164 K831291 000
20653405008900 K831291 000
10653405009160 K831291 000

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