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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 K850051
Device Name VERSA-FILL 120 & FILL SET 42-50
Applicant
Intl. Medical Industries
570 Pleasant St.
Watertown,  MA  02172
Applicant Contact JOHN P VITELLO
Correspondent
Intl. Medical Industries
570 Pleasant St.
Watertown,  MA  02172
Correspondent Contact JOHN P VITELLO
Regulation Number880.5440
Classification Product Code
LHI  
Date Received01/08/1985
Decision Date 03/06/1985
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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