EXCALIBUR PLUS 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 Excalibur Plus Electrosurgical Unit.

Pre-market Notification Details

Device IDK953007
510k NumberK953007
Device Name:EXCALIBUR PLUS ELECTROSURGICAL UNIT
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 Received1995-06-28
Decision Date1995-08-21

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10653405010999 K953007 000
10653405010975 K953007 000

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