PAIN CONTROL INFUSION PUMP

Pump, Infusion

SGARLATO LABORATORIES, INC.

The following data is part of a premarket notification filed by Sgarlato Laboratories, Inc. with the FDA for Pain Control Infusion Pump.

Pre-market Notification Details

Device IDK990101
510k NumberK990101
Device Name:PAIN CONTROL INFUSION PUMP
ClassificationPump, Infusion
Applicant SGARLATO LABORATORIES, INC. 250 ALMENDRA AVE. Los Gatos,  CA  95030
ContactThomas Sgarlato
CorrespondentThomas Sgarlato
SGARLATO LABORATORIES, INC. 250 ALMENDRA AVE. Los Gatos,  CA  95030
Product CodeFRN  
CFR Regulation Number880.5725 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-01-12
Decision Date1999-03-19
Summary:summary

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