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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, Administration, Intravascular
510(k) Number K854965
Device Name IN LINE VALVE CATALOG NO. 2000A
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 Number880.5440
Classification Product Code
FPA  
Date Received12/11/1985
Decision Date 02/21/1986
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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