Presto Inflation Device

Syringe, Balloon Inflation

C.R. BARD, INC.

The following data is part of a premarket notification filed by C.r. Bard, Inc. with the FDA for Presto Inflation Device.

Pre-market Notification Details

Device IDK143522
510k NumberK143522
Device Name:Presto Inflation Device
ClassificationSyringe, Balloon Inflation
Applicant C.R. BARD, INC. 1625 W.3RD STREET Tempe,  AZ  85281
ContactTimothy Wade
CorrespondentMark Job
REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul,  MN  55114
Product CodeMAV  
CFR Regulation Number870.1650 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2014-12-12
Decision Date2015-01-12
Summary:summary

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