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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 K960581
Device Name SECURE EVA DUAL CHAMBER MIXING BAG
Applicant
SECURE MEDICAL PRODUCTS, INC.
369 N. NEWCOMB ST.
WHITEWATER,  WI  53190
Applicant Contact LISA M BECK
Correspondent
SECURE MEDICAL PRODUCTS, INC.
369 N. NEWCOMB ST.
WHITEWATER,  WI  53190
Correspondent Contact LISA M BECK
Regulation Number880.5025
Classification Product Code
KPE  
Date Received02/12/1996
Decision Date 04/30/1996
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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