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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 K992266
Device Name IV ADMINISTRATION SET
Applicant
New Alliance of Independent Medical Distributors,
99 W. Sandra Ave.
Arcadia,  CA  91007
Applicant Contact EDWARD THIBON
Correspondent
New Alliance of Independent Medical Distributors,
99 W. Sandra Ave.
Arcadia,  CA  91007
Correspondent Contact EDWARD THIBON
Regulation Number880.5440
Classification Product Code
FPA  
Date Received07/06/1999
Decision Date 10/27/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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