MANUKA IG

Dressing, Wound, Drug

LINKS MEDICAL PRODUCTS, INC.

The following data is part of a premarket notification filed by Links Medical Products, Inc. with the FDA for Manuka Ig.

Pre-market Notification Details

Device IDK120976
510k NumberK120976
Device Name:MANUKA IG
ClassificationDressing, Wound, Drug
Applicant LINKS MEDICAL PRODUCTS, INC. 29442 POINTE ROYALE Laguna Niguel,  CA  92677
ContactJames Smith
CorrespondentJames Smith
LINKS MEDICAL PRODUCTS, INC. 29442 POINTE ROYALE Laguna Niguel,  CA  92677
Product CodeFRO  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductYes
Date Received2012-04-02
Decision Date2012-05-23
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10851028001374 K120976 000
10851028001350 K120976 000
10851028001169 K120976 000

Trademark Results [MANUKA IG]

Mark Image

Registration | Serial
Company
Trademark
Application Date
MANUKA IG
MANUKA IG
85385581 4441560 Live/Registered
Links Medical Products Inc.
2011-07-31

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