ExtriCARE Negative Pressure Wound Therapy Gel Strip - 8pc, ExtriCARE Negative Pressure Wound Therapy Gel Strip - 7pc, ExtriCARE Negative Pressure Wound Therapy Gel Strip - 6pc, ExtriCARE Negative Pressure Wound Therapy Gel Strip - 5pc, ExtriCARE Nega

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 Negative Pressure Wound Therapy Gel Strip - 8pc, Extricare Negative Pressure Wound Therapy Gel Strip - 7pc, Extricare Negative Pressure Wound Therapy Gel Strip - 6pc, Extricare Negative Pressure Wound Therapy Gel Strip - 5pc, Extricare Nega.

Pre-market Notification Details

Device IDK151240
510k NumberK151240
Device Name:ExtriCARE Negative Pressure Wound Therapy Gel Strip - 8pc, ExtriCARE Negative Pressure Wound Therapy Gel Strip - 7pc, ExtriCARE Negative Pressure Wound Therapy Gel Strip - 6pc, ExtriCARE Negative Pressure Wound Therapy Gel Strip - 5pc, ExtriCARE Nega
ClassificationNegative Pressure Wound Therapy Powered Suction Pump
Applicant Devon Medical Products 1100 First Avenue, Suite 202 King Of Prussia,  PA  19406
ContactJohn Siegel
CorrespondentSteve Xu
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 Received2015-05-11
Decision Date2015-06-09

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