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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 K843692
Device Name FLU VEN I.V. SET 0153-C PERMA-SET
Applicant
Venusa , Ltd.
750 Third Ave.
22nd. Floor
New York,  NY  10017
Applicant Contact RONALD J GUIDA
Correspondent
Venusa , Ltd.
750 Third Ave.
22nd. Floor
New York,  NY  10017
Correspondent Contact RONALD J GUIDA
Regulation Number880.5440
Classification Product Code
FPA  
Date Received09/19/1984
Decision Date 10/31/1984
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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