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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 K900336
Device Name V SET
Applicant
Go Medical Industries Pty. , Ltd.
200 Churchill Ave.
Subiaco, Perth,  AU 6008
Applicant Contact DAVID CAPES
Correspondent
Go Medical Industries Pty. , Ltd.
200 Churchill Ave.
Subiaco, Perth,  AU 6008
Correspondent Contact DAVID CAPES
Regulation Number880.5440
Classification Product Code
FPA  
Date Received01/23/1990
Decision Date 10/04/1990
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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