SOLACE POST-OPERATIVE PAIN RELIEF INFUSION SYSTEM

Pump, Infusion, Elastomeric

APEX MEDICAL TECHNOLOGIES, INC.

The following data is part of a premarket notification filed by Apex Medical Technologies, Inc. with the FDA for Solace Post-operative Pain Relief Infusion System.

Pre-market Notification Details

Device IDK060933
510k NumberK060933
Device Name:SOLACE POST-OPERATIVE PAIN RELIEF INFUSION SYSTEM
ClassificationPump, Infusion, Elastomeric
Applicant APEX MEDICAL TECHNOLOGIES, INC. 10064 MESA RIDGE CT., #202 San Diego,  CA  92121
ContactWhitney Williams
CorrespondentRobert Mosenkis
CITECH 5200 BUTLER PIKE Plymouth Meeting,  PA  19462 -1298
Product CodeMEB  
CFR Regulation Number880.5725 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2006-04-05
Decision Date2006-05-09
Summary:summary

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