MPS GRAVITY FLOW CONTROL SET

Set, Administration, Intravascular

CRITICAL DEVICE CORP.

The following data is part of a premarket notification filed by Critical Device Corp. with the FDA for Mps Gravity Flow Control Set.

Pre-market Notification Details

Device IDK983926
510k NumberK983926
Device Name:MPS GRAVITY FLOW CONTROL SET
ClassificationSet, Administration, Intravascular
Applicant CRITICAL DEVICE CORP. 499 NIBUS ST. Brea,  CA  92621
ContactDan Hyun
CorrespondentDan Hyun
CRITICAL DEVICE CORP. 499 NIBUS ST. Brea,  CA  92621
Product CodeFPA  
CFR Regulation Number880.5440 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-11-05
Decision Date1999-01-20
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00816513023531 K983926 000

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