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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 K860434
Device Name CHEMO-VENT
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 Received02/04/1986
Decision Date 02/12/1986
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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