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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Clamp, Line
510(k) Number K854512
Device Name TUBING CLAMP CAT#1000-A
Applicant
Rao Medical Devices, Inc.
P.O. Box 621, 1550 Winchell
Drive
Hudson,  OH  44236
Applicant Contact ROLF A OSCARSSON
Correspondent
Rao Medical Devices, Inc.
P.O. Box 621, 1550 Winchell
Drive
Hudson,  OH  44236
Correspondent Contact ROLF A OSCARSSON
Regulation Number876.4730
Classification Product Code
FKK  
Date Received11/12/1985
Decision Date 12/02/1985
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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