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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Protector, Transducer, Dialysis
510(k) Number K902788
Device Name CLEM TM
Applicant
Arbo Medical, Inc.
3728 Plz. Dr.
Ann Arbor,  MI  48108
Applicant Contact DAWN MOORE
Correspondent
Arbo Medical, Inc.
3728 Plz. Dr.
Ann Arbor,  MI  48108
Correspondent Contact DAWN MOORE
Regulation Number876.5820
Classification Product Code
FIB  
Date Received06/26/1990
Decision Date 09/12/1990
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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