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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Stretcher, Wheeled
510(k) Number K853421
Device Name THE KEYMED VARI-HEIGHT PATIENT COUCH
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 Number880.6910
Classification Product Code
FPO  
Date Received08/14/1985
Decision Date 09/19/1985
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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