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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 K862282
Device Name RAPIDEX BIOLOGICAL SURFACTANT
Applicant
Rapidex of London
2 Eversfield Rd., Kew Tw9 2ap
Richmond, Surrey,  GB
Applicant Contact UPTON
Correspondent
Rapidex of London
2 Eversfield Rd., Kew Tw9 2ap
Richmond, Surrey,  GB
Correspondent Contact UPTON
Regulation Number880.6150
Classification Product Code
FLG  
Date Received06/16/1986
Decision Date 05/11/1987
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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