DOLPHIN INFLATION DEVICE

Syringe, Balloon Inflation

SEDAT S.A.

The following data is part of a premarket notification filed by Sedat S.a. with the FDA for Dolphin Inflation Device.

Pre-market Notification Details

Device IDK042449
510k NumberK042449
Device Name:DOLPHIN INFLATION DEVICE
ClassificationSyringe, Balloon Inflation
Applicant SEDAT S.A. 45900 PARSIPPANY COURT Temecula,  CA  92592
ContactLaetitia Bernard
CorrespondentLaetitia Bernard
SEDAT S.A. 45900 PARSIPPANY COURT Temecula,  CA  92592
Product CodeMAV  
CFR Regulation Number870.1650 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-09-09
Decision Date2005-04-18
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
23661234017533 K042449 000
23661234017526 K042449 000
23661234017366 K042449 000

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