MANI NEEDLE & SUTURE PACK (NYLON)

Suture, Nonabsorbable, Synthetic, Polyamide

MANI, INC.

The following data is part of a premarket notification filed by Mani, Inc. with the FDA for Mani Needle & Suture Pack (nylon).

Pre-market Notification Details

Device IDK053637
510k NumberK053637
Device Name:MANI NEEDLE & SUTURE PACK (NYLON)
ClassificationSuture, Nonabsorbable, Synthetic, Polyamide
Applicant MANI, INC. 1301K STREET, N.W. SUITE 1100 - EAST TOWER Washington,  DC  20005 -3373
ContactDavid J Bloch
CorrespondentDavid J Bloch
MANI, INC. 1301K STREET, N.W. SUITE 1100 - EAST TOWER Washington,  DC  20005 -3373
Product CodeGAR  
CFR Regulation Number878.5020 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-12-29
Decision Date2006-05-19
Summary:summary

NIH GUDID Devices

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