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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Refractometer For Clinical Use
510(k) Number K891681
Device Name DILECTRON URINARY CONDUCTIVITY PROBE
Applicant
Gyrus Medical , Ltd.
Chapel Cottage Milton Combe
Yelverton Devon Pl20 6hp
England,  GB
Applicant Contact GOBLE
Correspondent
Gyrus Medical , Ltd.
Chapel Cottage Milton Combe
Yelverton Devon Pl20 6hp
England,  GB
Correspondent Contact GOBLE
Regulation Number862.2800
Classification Product Code
JRE  
Date Received03/22/1989
Decision Date 05/01/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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