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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name system, alarm, electrosurgical
510(k) Number K843214
Device Name EPHAR
Applicant
AKRON CITY HOSPITAL
525 E. MARKET ST.
AKRON,  OH  44309
Applicant Contact TIMOTHY A BODNER
Correspondent
AKRON CITY HOSPITAL
525 E. MARKET ST.
AKRON,  OH  44309
Correspondent Contact TIMOTHY A BODNER
Regulation Number876.4300
Classification Product Code
FFI  
Date Received08/15/1984
Decision Date 11/29/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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