VANGUARD REPROCESSED INFLATION DEVICES

Syringe, Balloon Inflation

VANGUARD MEDICAL CONCEPTS, INC.

The following data is part of a premarket notification filed by Vanguard Medical Concepts, Inc. with the FDA for Vanguard Reprocessed Inflation Devices.

Pre-market Notification Details

Device IDK012480
510k NumberK012480
Device Name:VANGUARD REPROCESSED INFLATION DEVICES
ClassificationSyringe, Balloon Inflation
Applicant VANGUARD MEDICAL CONCEPTS, INC. 5307 GREAT OAK DR. Lakeland,  FL  33815
ContactMike Sammon
CorrespondentMike Sammon
VANGUARD MEDICAL CONCEPTS, INC. 5307 GREAT OAK DR. Lakeland,  FL  33815
Product CodeMAV  
CFR Regulation Number870.1650 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-08-02
Decision Date2002-01-22
Summary:summary

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