SINGLE USE SYRINGE #103 PERSONAL MEDIC

Pump, Infusion

PACESETTER SYSTEMS

The following data is part of a premarket notification filed by Pacesetter Systems with the FDA for Single Use Syringe #103 Personal Medic.

Pre-market Notification Details

Device IDK831444
510k NumberK831444
Device Name:SINGLE USE SYRINGE #103 PERSONAL MEDIC
ClassificationPump, Infusion
Applicant PACESETTER SYSTEMS 4221 Richmond Rd., N.W. Walker,  MI  49534
Product CodeFRN  
CFR Regulation Number880.5725 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1983-05-05
Decision Date1983-09-12

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