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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Filter, Infusion Line
510(k) Number K860372
Device Name FAST FLOW XX (AQUEOUS SOLUTION FILTER)
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
FPB  
Date Received02/03/1986
Decision Date 05/30/1986
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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