OPERATING ROOM TRAY

Tray, Surgical, Instrument

MEDICAL DESIGN CONCEPTS, INC.

The following data is part of a premarket notification filed by Medical Design Concepts, Inc. with the FDA for Operating Room Tray.

Pre-market Notification Details

Device IDK860160
510k NumberK860160
Device Name:OPERATING ROOM TRAY
ClassificationTray, Surgical, Instrument
Applicant MEDICAL DESIGN CONCEPTS, INC. 5741 PALMER WAY Carlsbad,  CA  92008
ContactRonald Bertanzi
CorrespondentRonald Bertanzi
MEDICAL DESIGN CONCEPTS, INC. 5741 PALMER WAY Carlsbad,  CA  92008
Product CodeFSM  
CFR Regulation Number878.4800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-01-16
Decision Date1986-02-27

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