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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 K915109
Device Name RAPID ADD SITE DOUBLE LUMEN I.V.EXTENSION SET
Applicant
Ballard Medical Products
12050 Lone Peak Pkwy.
Draper,  UT  84020
Applicant Contact E.MARTIN CHAMBERLAIN
Correspondent
Ballard Medical Products
12050 Lone Peak Pkwy.
Draper,  UT  84020
Correspondent Contact E.MARTIN CHAMBERLAIN
Regulation Number880.5440
Classification Product Code
FPA  
Date Received11/13/1991
Decision Date 05/08/1992
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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