SUPRAFLOW CONSOLE

Pump, Portable, Aspiration (manual Or Powered)

NEOMEDIX CORP.

The following data is part of a premarket notification filed by Neomedix Corp. with the FDA for Supraflow Console.

Pre-market Notification Details

Device IDK040239
510k NumberK040239
Device Name:SUPRAFLOW CONSOLE
ClassificationPump, Portable, Aspiration (manual Or Powered)
Applicant NEOMEDIX CORP. 27452 CALLE ARROYO San Juan Capistrano,  CA  92675 -2748
ContactSoheila Mirhashemi
CorrespondentMarc M Mouser
UNDERWRITERS LABORATORIES, INC. 2600 NW LAKE RD. Camas,  WA  98607 -9526
Product CodeBTA  
CFR Regulation Number878.4780 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2004-02-02
Decision Date2004-02-17
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00854028002023 K040239 000

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