PROCEDUR-10

Syringe, Piston

AVANCA MEDICAL DEVICES, INC.

The following data is part of a premarket notification filed by Avanca Medical Devices, Inc. with the FDA for Procedur-10.

Pre-market Notification Details

Device IDK052075
510k NumberK052075
Device Name:PROCEDUR-10
ClassificationSyringe, Piston
Applicant AVANCA MEDICAL DEVICES, INC. 801 UNIVERSITY BLVD. SE SUITE 307 Albuquerque,  NM  87106
ContactFrank Ferguson
CorrespondentFrank Ferguson
AVANCA MEDICAL DEVICES, INC. 801 UNIVERSITY BLVD. SE SUITE 307 Albuquerque,  NM  87106
Product CodeFMF  
CFR Regulation Number880.5860 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-08-01
Decision Date2005-11-09
Summary:summary

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