SIMEX SUCTION PUMP, MODELS AC20, AC20K, AC30, DC20, DC30 AND DC30S

Pump, Portable, Aspiration (manual Or Powered)

NOVASPINE LLC

The following data is part of a premarket notification filed by Novaspine Llc with the FDA for Simex Suction Pump, Models Ac20, Ac20k, Ac30, Dc20, Dc30 And Dc30s.

Pre-market Notification Details

Device IDK061133
510k NumberK061133
Device Name:SIMEX SUCTION PUMP, MODELS AC20, AC20K, AC30, DC20, DC30 AND DC30S
ClassificationPump, Portable, Aspiration (manual Or Powered)
Applicant NOVASPINE LLC PO BOX 969 Elmsford,  NY  10523
ContactHamid Khosrowshahi
CorrespondentHamid Khosrowshahi
NOVASPINE LLC PO BOX 969 Elmsford,  NY  10523
Product CodeBTA  
CFR Regulation Number878.4780 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-04-24
Decision Date2006-07-11
Summary:summary

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