NPseal

Negative Pressure Wound Therapy Non-powered Suction Apparatus

Guard Medical Inc.

The following data is part of a premarket notification filed by Guard Medical Inc. with the FDA for Npseal.

Pre-market Notification Details

Device IDK211130
510k NumberK211130
Device Name:NPseal
ClassificationNegative Pressure Wound Therapy Non-powered Suction Apparatus
Applicant Guard Medical Inc. 1221 Brickell Avenue, Suite 900 Miami,  FL  33131
ContactMachiel Van Der Leest
CorrespondentEric Bannon
AlvaMed, Inc. 935 Great Plain Avenue, Unit 166 Needham,  MA  02492
Product CodeOKO  
CFR Regulation Number878.4683 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-04-16
Decision Date2021-05-14

Trademark Results [NPseal]

Mark Image

Registration | Serial
Company
Trademark
Application Date
NPSEAL
NPSEAL
88000721 not registered Live/Pending
Guard Medical SAS
2018-06-14

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