SGARLATO LABS PAINFREE PUMP AND 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 Sgarlato Labs Painfree Pump And Pain Control Infusion Pump.

Pre-market Notification Details

Device IDK043204
510k NumberK043204
Device Name:SGARLATO LABS PAINFREE PUMP AND PAIN CONTROL INFUSION PUMP
ClassificationPump, Infusion
Applicant SGARLATO LABORATORIES, INC. 2315 SO. BASCOM QUALITY MANAGEMENT Campbell,  CA  95008
ContactMichael Mcdougall
CorrespondentMichael Mcdougall
SGARLATO LABORATORIES, INC. 2315 SO. BASCOM QUALITY MANAGEMENT Campbell,  CA  95008
Product CodeFRN  
CFR Regulation Number880.5725 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-11-18
Decision Date2005-03-30
Summary:summary

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