EXTRICARE NPWT FOOT DRESSING

Negative Pressure Wound Therapy Powered Suction Pump

DEVON MEDICAL INC.

The following data is part of a premarket notification filed by Devon Medical Inc. with the FDA for Extricare Npwt Foot Dressing.

Pre-market Notification Details

Device IDK131464
510k NumberK131464
Device Name:EXTRICARE NPWT FOOT DRESSING
ClassificationNegative Pressure Wound Therapy Powered Suction Pump
Applicant DEVON MEDICAL INC. 1100 1ST AVENUE SUITE 200 King Of Prussia,  PA  19406
ContactRuth Wu
CorrespondentRuth Wu
DEVON MEDICAL INC. 1100 1ST AVENUE SUITE 200 King Of Prussia,  PA  19406
Product CodeOMP  
CFR Regulation Number878.4780 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-05-21
Decision Date2013-08-13

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
20879766005635 K131464 000

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