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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 K863040
Device Name DISPOSABLE INTRAVENOUS HYPERALIMENTATION BAGS
Applicant
Cher Mel Corp.
P.O. Box 68624
Seattle,  WA  98168
Applicant Contact CHERYL AMUNDSEN
Correspondent
Cher Mel Corp.
P.O. Box 68624
Seattle,  WA  98168
Correspondent Contact CHERYL AMUNDSEN
Regulation Number880.5025
Classification Product Code
KPE  
Date Received08/12/1986
Decision Date 10/31/1986
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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