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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, Administration, For Peritoneal Dialysis, Disposable
510(k) Number K871583
Device Name MODIFIED LABELING FOR AMUKIN-50%
Applicant
Amuchina Intl., Inc.
12120a Heritage Park Cir.
Silver Spring,  MD  20906
Applicant Contact COONEY, PA
Correspondent
Amuchina Intl., Inc.
12120a Heritage Park Cir.
Silver Spring,  MD  20906
Correspondent Contact COONEY, PA
Regulation Number876.5630
Classification Product Code
KDJ  
Date Received04/23/1987
Decision Date 07/09/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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