PROCEDUR SF SAFETY SYRINGE DEVICE

Syringe, Antistick

AVANCA MEDICAL DEVICES, INC.

The following data is part of a premarket notification filed by Avanca Medical Devices, Inc. with the FDA for Procedur Sf Safety Syringe Device.

Pre-market Notification Details

Device IDK042487
510k NumberK042487
Device Name:PROCEDUR SF SAFETY SYRINGE DEVICE
ClassificationSyringe, Antistick
Applicant AVANCA MEDICAL DEVICES, INC. 12200 ACADEMY ROAD NE # 931 Albuquerque,  NM  87111
ContactFrank Ferguson
CorrespondentFrank Ferguson
AVANCA MEDICAL DEVICES, INC. 12200 ACADEMY ROAD NE # 931 Albuquerque,  NM  87111
Product CodeMEG  
CFR Regulation Number880.5860 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-09-13
Decision Date2005-01-21
Summary:summary

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