PDO Max Suture With Dual Needle

Suture, Surgical, Absorbable, Polydioxanone

PDO MAX, Inc.

The following data is part of a premarket notification filed by Pdo Max, Inc. with the FDA for Pdo Max Suture With Dual Needle.

Pre-market Notification Details

Device IDK210871
510k NumberK210871
Device Name:PDO Max Suture With Dual Needle
ClassificationSuture, Surgical, Absorbable, Polydioxanone
Applicant PDO MAX, Inc. 4971 Bear Road Liverpool,  NY  13088
ContactGiovanna Mccarthy
CorrespondentMary Vater
Medical Device Academy, Inc. 345 Lincoln Hill Rd. Shrewsbury,  VT  05738
Product CodeNEW  
CFR Regulation Number878.4840 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-03-24
Decision Date2021-12-17

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