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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 K802765
Device Name ACRODISC FILTER ASSEMBLY
Applicant
GELMAN SCIENCES, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
GELMAN SCIENCES, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number880.5440
Classification Product Code
FPB  
Date Received11/04/1980
Decision Date 01/21/1981
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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