TRANSPORT CART

System, Balloon, Intra-aortic And Control

BELMONT INSTRUMENT CORP.

The following data is part of a premarket notification filed by Belmont Instrument Corp. with the FDA for Transport Cart.

Pre-market Notification Details

Device IDK952576
510k NumberK952576
Device Name:TRANSPORT CART
ClassificationSystem, Balloon, Intra-aortic And Control
Applicant BELMONT INSTRUMENT CORP. 780 BOSTON RD. Billerica,  MA  01821
ContactUraiwan P Labadini
CorrespondentUraiwan P Labadini
BELMONT INSTRUMENT CORP. 780 BOSTON RD. Billerica,  MA  01821
Product CodeDSP  
CFR Regulation Number870.3535 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-06-05
Decision Date1995-12-26

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