TUTA HEALTHCARE ARTHROSCOPY FLUSHING SET, MODEL 80.601

Arthroscope

TUTA HEALTHCARE PTY LIMITED

The following data is part of a premarket notification filed by Tuta Healthcare Pty Limited with the FDA for Tuta Healthcare Arthroscopy Flushing Set, Model 80.601.

Pre-market Notification Details

Device IDK020083
510k NumberK020083
Device Name:TUTA HEALTHCARE ARTHROSCOPY FLUSHING SET, MODEL 80.601
ClassificationArthroscope
Applicant TUTA HEALTHCARE PTY LIMITED 318-332 BURNS BAY ROAD LANE COVE Sydney Nsw,  AU 2066
ContactOmid Souresrafil
CorrespondentOmid Souresrafil
TUTA HEALTHCARE PTY LIMITED 318-332 BURNS BAY ROAD LANE COVE Sydney Nsw,  AU 2066
Product CodeHRX  
CFR Regulation Number888.1100 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-01-10
Decision Date2002-02-12
Summary:summary

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