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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dialyzer, Capillary, Hollow Fiber
510(k) Number K991908
Device Name IDEMSA HEMOPHAN HOLLOW FIBER DIALYZERS
Applicant
Idemsa
1600 Stewart Ave.
Westbury,  NY  11590
Applicant Contact LEON LACHMAN
Correspondent
Idemsa
1600 Stewart Ave.
Westbury,  NY  11590
Correspondent Contact LEON LACHMAN
Regulation Number876.5820
Classification Product Code
FJI  
Date Received06/07/1999
Decision Date 04/17/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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