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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 K812928
Device Name VACU-FIL TRANSFER SET
Applicant
American Pharmaseal Div. Ahsc
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
American Pharmaseal Div. Ahsc
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number880.5440
Classification Product Code
LHI  
Date Received10/19/1981
Decision Date 12/30/1981
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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