VARIOUS CARDIAC CRYOPROBES HAVING DIA. & COS. DIFF

Unit, Cautery, Thermal, Ac-powered

SPEMBLY MEDICAL LTD.

The following data is part of a premarket notification filed by Spembly Medical Ltd. with the FDA for Various Cardiac Cryoprobes Having Dia. & Cos. Diff.

Pre-market Notification Details

Device IDK874367
510k NumberK874367
Device Name:VARIOUS CARDIAC CRYOPROBES HAVING DIA. & COS. DIFF
ClassificationUnit, Cautery, Thermal, Ac-powered
Applicant SPEMBLY MEDICAL LTD. NEWBURY ROAD ANDOVER HAMPSHIRE SP10 4DR England,  GB
ContactGordon Cook
CorrespondentGordon Cook
SPEMBLY MEDICAL LTD. NEWBURY ROAD ANDOVER HAMPSHIRE SP10 4DR England,  GB
Product CodeHQO  
CFR Regulation Number886.4115 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-10-23
Decision Date1988-01-04

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