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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cleaner, Ultrasonic, Medical Instrument
510(k) Number K861147
Device Name UCS-2, ULTRASONIC CLEANING SOLUTION
Applicant
Keymed, Inc.
Keymed House, Stock Rd.
Southend-On-Sea
Essex Ss2 5qh England,  GB
Applicant Contact R. L GRAY
Correspondent
Keymed, Inc.
Keymed House, Stock Rd.
Southend-On-Sea
Essex Ss2 5qh England,  GB
Correspondent Contact R. L GRAY
Regulation Number880.6150
Classification Product Code
FLG  
Date Received03/26/1986
Decision Date 06/23/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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