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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 K861182
Device Name TIMELINE VENIPUNCTURE SYSTEM
Applicant
Ipax, Inc.
2109 W. Amherst Ave.
Englewood,  CO  80110
Applicant Contact PHILLIP PENNELL
Correspondent
Ipax, Inc.
2109 W. Amherst Ave.
Englewood,  CO  80110
Correspondent Contact PHILLIP PENNELL
Regulation Number880.5440
Classification Product Code
FPA  
Date Received03/31/1986
Decision Date 06/04/1986
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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