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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 K926123
Device Name DUAL CHAMBER MIXING BAG
Applicant
SECURE MEDICAL, INC.
1000 ALLANSON RD.
MUNDELEIN,  IL  60060
Applicant Contact TED D LYJAK
Correspondent
SECURE MEDICAL, INC.
1000 ALLANSON RD.
MUNDELEIN,  IL  60060
Correspondent Contact TED D LYJAK
Regulation Number880.5025
Classification Product Code
KPE  
Date Received12/04/1992
Decision Date 09/03/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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