OPEN HEART TRAY

Tray, Surgical, Instrument

MEDICAL DEVICE INSPECTION CO., INC.

The following data is part of a premarket notification filed by Medical Device Inspection Co., Inc. with the FDA for Open Heart Tray.

Pre-market Notification Details

Device IDK912053
510k NumberK912053
Device Name:OPEN HEART TRAY
ClassificationTray, Surgical, Instrument
Applicant MEDICAL DEVICE INSPECTION CO., INC. 55 NORTHERN BLVD. SUITE 301 Great Neck,  NY  11021
ContactAlan P.schwartz
CorrespondentAlan P.schwartz
MEDICAL DEVICE INSPECTION CO., INC. 55 NORTHERN BLVD. SUITE 301 Great Neck,  NY  11021
Product CodeFSM  
CFR Regulation Number878.4800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-05-09
Decision Date1991-08-26

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