UCS-2, ULTRASONIC CLEANING SOLUTION

Cleaner, Ultrasonic, Medical Instrument

KEYMED, INC.

The following data is part of a premarket notification filed by Keymed, Inc. with the FDA for Ucs-2, Ultrasonic Cleaning Solution.

Pre-market Notification Details

Device IDK861147
510k NumberK861147
Device Name:UCS-2, ULTRASONIC CLEANING SOLUTION
ClassificationCleaner, Ultrasonic, Medical Instrument
Applicant KEYMED, INC. KEYMED HOUSE, STOCK ROAD SOUTHEND-ON-SEA Essex Ss2 5qh England,  GB
ContactR. L Gray
CorrespondentR. L Gray
KEYMED, INC. KEYMED HOUSE, STOCK ROAD SOUTHEND-ON-SEA Essex Ss2 5qh England,  GB
Product CodeFLG  
CFR Regulation Number880.6150 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-03-26
Decision Date1986-06-23

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