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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 K871843
Device Name TWO FLUID W/CHECK VALVE
Applicant
Panamedix, Inc.
1308-E Logan Ave.
Costa Mesa,  CA  92626
Applicant Contact CARL W JOHNSTON
Correspondent
Panamedix, Inc.
1308-E Logan Ave.
Costa Mesa,  CA  92626
Correspondent Contact CARL W JOHNSTON
Regulation Number880.5440
Classification Product Code
FPA  
Date Received05/12/1987
Decision Date 07/21/1987
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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