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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Table, Cystometric, Non-Electric And Accessories
510(k) Number K860040
Device Name HYDRAJUST III UROLOGICAL TABLE
Applicant
Mallinckrodt Group, Inc.
2111 E. Galbraith Rd.
P.O. Box 156305
Cincinnati,  OH  45215
Applicant Contact JAMES S ADAMS
Correspondent
Mallinckrodt Group, Inc.
2111 E. Galbraith Rd.
P.O. Box 156305
Cincinnati,  OH  45215
Correspondent Contact JAMES S ADAMS
Regulation Number876.4890
Classification Product Code
KQS  
Date Received01/06/1986
Decision Date 02/10/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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