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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Washer, Cleaner, Automated, Endoscope
510(k) Number K861821
Device Name KEYMED FIBERSCOPE AUTO DISINFECTOR
Applicant
Keymed, Inc.
Keymed House, Stock Rd.
Southend-On-Sea
Essex Ss2 5qh England,  GB
Applicant Contact ROGER GRAY
Correspondent
Keymed, Inc.
Keymed House, Stock Rd.
Southend-On-Sea
Essex Ss2 5qh England,  GB
Correspondent Contact ROGER GRAY
Regulation Number876.1500
Classification Product Code
NVE  
Date Received05/12/1986
Decision Date 02/12/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
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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