FDA.report

510(k) K041381

Device
MEROPACK BIORESORBABLE NASAL PACKING AND SINUS STENT
Applicant
MEDTRONIC XOMED, INC.
510(k) number
K041381
Product code
LYA  
Decision
Substantially Equivalent (SESE)
Decision date
2004-09-10
Date received
2004-05-25
Regulation
874.4780
Classification name
Splint, Intranasal Septal
Medical specialty
Ear Nose & Throat
Review panel
Ear Nose & Throat
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
DAVID S DODD
Address
6743 Southpoint Dr. N. Jacksonville FL US 32216 32216

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

Related GUDID Devices

Primary DIBrandCompanyPublished
20885074137791MeroPack™MEDTRONIC XOMED, INC.2017-02-17
20885074137777MeroPack™MEDTRONIC XOMED, INC.2016-04-30

Legacy Summary

summary

FDA Review

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