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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 K852029
Device Name I.V. WATCH
Applicant
Alltek, Inc.
P.O. Box 1130
Nevada City,  CA  95959
Applicant Contact CLIFFORD A TYNER
Correspondent
Alltek, Inc.
P.O. Box 1130
Nevada City,  CA  95959
Correspondent Contact CLIFFORD A TYNER
Regulation Number880.5440
Classification Product Code
FPB  
Date Received05/08/1985
Decision Date 05/30/1985
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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