PROSPERA PRO-I, PRO-II AND PRO-III NEGATIVE PRESSURE WOUND THERAPY SYSTEM

Negative Pressure Wound Therapy Powered Suction Pump

MEDICA-RENTS CO., LTD.

The following data is part of a premarket notification filed by Medica-rents Co., Ltd. with the FDA for Prospera Pro-i, Pro-ii And Pro-iii Negative Pressure Wound Therapy System.

Pre-market Notification Details

Device IDK112458
510k NumberK112458
Device Name:PROSPERA PRO-I, PRO-II AND PRO-III NEGATIVE PRESSURE WOUND THERAPY SYSTEM
ClassificationNegative Pressure Wound Therapy Powered Suction Pump
Applicant MEDICA-RENTS CO., LTD. P.O. BOX 205 Derby,  CT  06418
ContactDina L Weissman, J.d.
CorrespondentDina L Weissman, J.d.
MEDICA-RENTS CO., LTD. P.O. BOX 205 Derby,  CT  06418
Product CodeOMP  
CFR Regulation Number878.4780 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-08-26
Decision Date2012-01-05
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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00749756392457 K112458 000

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