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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 K941628
Device Name 40 MICRON BLOOD TRANSFUSION FILTER
Applicant
Douglas Medical Products Corp.
345 Dunbar Rd.
Mundelein,  IL  60060
Applicant Contact DOUGLAS JOHNSON
Correspondent
Douglas Medical Products Corp.
345 Dunbar Rd.
Mundelein,  IL  60060
Correspondent Contact DOUGLAS JOHNSON
Regulation Number880.5440
Classification Product Code
FPB  
Date Received04/04/1994
Decision Date 02/16/1995
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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