SURGIPHOR Wound Irrigation System

Lavage, Jet

Orthophor, LLC

The following data is part of a premarket notification filed by Orthophor, Llc with the FDA for Surgiphor Wound Irrigation System.

Pre-market Notification Details

Device IDK202071
510k NumberK202071
Device Name:SURGIPHOR Wound Irrigation System
ClassificationLavage, Jet
Applicant Orthophor, LLC 125 S. 9th Street Sheridan Building, Suite 1001 Philadelphia,  PA  19107
ContactAlan Miller
CorrespondentElizabeth O’keeffe
Secure BioMed Evaluations 7828 Hickory Flat Highway Suite 120 Woodstock,  GA  30188
Product CodeFQH  
CFR Regulation Number880.5475 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductYes
Date Received2020-07-27
Decision Date2020-10-23

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