SYSTEM 7500 ABC ELECTROSURGICAL UNIT

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 System 7500 Abc Electrosurgical Unit.

Pre-market Notification Details

Device IDK981220
510k NumberK981220
Device Name:SYSTEM 7500 ABC ELECTROSURGICAL UNIT
ClassificationElectrosurgical, Cutting & Coagulation & Accessories
Applicant ASPEN LABORATORIES, INC. 14603 E. FREMONT AVE. Englewood,  CO  80112
ContactCharles (mike) M Hart
CorrespondentCharles (mike) 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 Received1998-04-03
Decision Date1998-04-21

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
40653405033593 K981220 000
10653405069096 K981220 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.