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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Container, I.V.
510(k) Number K932640
Device Name EVA EMPTY MIXING CONTAINER
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 Number880.5025
Classification Product Code
KPE  
Date Received06/02/1993
Decision Date 11/10/1993
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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