POLYPERF / POLYPERF SAFE

Set, Administration, Intravascular

LABORATOIRES PEROUSE

The following data is part of a premarket notification filed by Laboratoires Perouse with the FDA for Polyperf / Polyperf Safe.

Pre-market Notification Details

Device IDK063631
510k NumberK063631
Device Name:POLYPERF / POLYPERF SAFE
ClassificationSet, Administration, Intravascular
Applicant LABORATOIRES PEROUSE Route Du Manoir Ivry Le Temple,  FR 60173
ContactMarie Noelle Erout
CorrespondentMarie Noelle Erout
LABORATOIRES PEROUSE Route Du Manoir Ivry Le Temple,  FR 60173
Product CodeFPA  
CFR Regulation Number880.5440 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-12-06
Decision Date2007-10-05
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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13661234013910 K063631 000

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