MR-5200 FULL DISCLOSURE SYSTEM

Recorder, Magnetic Tape, Medical

MENNEN MEDICAL, INC.

The following data is part of a premarket notification filed by Mennen Medical, Inc. with the FDA for Mr-5200 Full Disclosure System.

Pre-market Notification Details

Device IDK911257
510k NumberK911257
Device Name:MR-5200 FULL DISCLOSURE SYSTEM
ClassificationRecorder, Magnetic Tape, Medical
Applicant MENNEN MEDICAL, INC. 10123 MAIN ST. Clarence,  NY  14031
ContactRichard Whitehead
CorrespondentRichard Whitehead
MENNEN MEDICAL, INC. 10123 MAIN ST. Clarence,  NY  14031
Product CodeDSH  
CFR Regulation Number870.2800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-03-21
Decision Date1991-08-19

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