ExtriCARE 3600 Negative Pressure Wound Therapy System 1000cc Canister

Negative Pressure Wound Therapy Powered Suction Pump

Devon Medical Products

The following data is part of a premarket notification filed by Devon Medical Products with the FDA for Extricare 3600 Negative Pressure Wound Therapy System 1000cc Canister.

Pre-market Notification Details

Device IDK143362
510k NumberK143362
Device Name:ExtriCARE 3600 Negative Pressure Wound Therapy System 1000cc Canister
ClassificationNegative Pressure Wound Therapy Powered Suction Pump
Applicant Devon Medical Products 1100 First Avenue, Suite 202 King Of Prussia,  PA  19406
ContactJohn Siegel
CorrespondentRocco Bravoco
Devon Medical Products 1100 First Avenue, Suite 202 King Of Prussia,  PA  19406
Product CodeOMP  
CFR Regulation Number878.4780 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-11-24
Decision Date2015-02-03

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
14897089070047 K143362 000

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