INSTRUMENT TRAY

Tray, Surgical, Instrument

MEDFUSION SYSTEMS, INC.

The following data is part of a premarket notification filed by Medfusion Systems, Inc. with the FDA for Instrument Tray.

Pre-market Notification Details

Device IDK772266
510k NumberK772266
Device Name:INSTRUMENT TRAY
ClassificationTray, Surgical, Instrument
Applicant MEDFUSION SYSTEMS, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeFSM  
CFR Regulation Number878.4800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1977-12-09
Decision Date1978-01-20

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