POWRSYRINGE MONITOR

Syringe, Piston

PINYONS MEDICAL TECHNOLOGY, INC.

The following data is part of a premarket notification filed by Pinyons Medical Technology, Inc. with the FDA for Powrsyringe Monitor.

Pre-market Notification Details

Device IDK072345
510k NumberK072345
Device Name:POWRSYRINGE MONITOR
ClassificationSyringe, Piston
Applicant PINYONS MEDICAL TECHNOLOGY, INC. 5010 HEUGA CT. Park City,  UT  84098
ContactShawn P Fojtik
CorrespondentMark Job
REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul,  MN  55114
Product CodeFMF  
CFR Regulation Number880.5860 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2007-08-21
Decision Date2007-09-21
Summary:summary

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