ANTLIA I WOUND IRRIGATION SYSTEM

Negative Pressure Wound Therapy Powered Suction Pump

INNOVATIVE THERAPIES, INC.

The following data is part of a premarket notification filed by Innovative Therapies, Inc. with the FDA for Antlia I Wound Irrigation System.

Pre-market Notification Details

Device IDK071301
510k NumberK071301
Device Name:ANTLIA I WOUND IRRIGATION SYSTEM
ClassificationNegative Pressure Wound Therapy Powered Suction Pump
Applicant INNOVATIVE THERAPIES, INC. 11 VENDUE COURT Simpsonville,  SC  29681
ContactJudith Harbour
CorrespondentMark Job
REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul,  MN  55114
Product CodeOMP  
CFR Regulation Number878.4780 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2007-05-09
Decision Date2007-05-24
Summary:summary

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