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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, I.V. Fluid Transfer
510(k) Number K874495
Device Name ADCOMP 4000 HP SYSTEM
Applicant
HEALTHTEK, INC.
870 GOLD FLAT RD.
P.O. BOX 1130
NEVADA CITY,  CA  95959
Applicant Contact CLIFFORD A TYNER
Correspondent
HEALTHTEK, INC.
870 GOLD FLAT RD.
P.O. BOX 1130
NEVADA CITY,  CA  95959
Correspondent Contact CLIFFORD A TYNER
Regulation Number880.5440
Classification Product Code
LHI  
Date Received11/02/1987
Decision Date 02/16/1988
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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