MACLIN POWER INTRAVASCULAR ADMINISTRATION SET

Set, Administration, Intravascular

MACLIN POWER INC.

The following data is part of a premarket notification filed by Maclin Power Inc. with the FDA for Maclin Power Intravascular Administration Set.

Pre-market Notification Details

Device IDK121511
510k NumberK121511
Device Name:MACLIN POWER INTRAVASCULAR ADMINISTRATION SET
ClassificationSet, Administration, Intravascular
Applicant MACLIN POWER INC. VIA MARZIA, 9 Abano Terme, Pd,  IT 35031
ContactEnrico Bisson
CorrespondentEnrico Bisson
MACLIN POWER INC. VIA MARZIA, 9 Abano Terme, Pd,  IT 35031
Product CodeFPA  
CFR Regulation Number880.5440 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-05-21
Decision Date2013-03-07
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00810083350875 K121511 000
00810083350516 K121511 000
00810083350899 K121511 000
00810083350912 K121511 000
00810083350936 K121511 000
00810083350967 K121511 000
00810083350974 K121511 000
00810083350431 K121511 000
00810083350417 K121511 000
00810083350387 K121511 000
00810083350394 K121511 000
00810083350400 K121511 000
00810083350257 K121511 000
00810083350370 K121511 000
00810083350844 K121511 000
00810083350455 K121511 000

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