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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Evacuator, Gastro-Urology
510(k) Number K811779
Device Name ROSS-EMERSON PUMP, MODEL 55-R
Applicant
J. H. Emerson Co.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
J. H. Emerson Co.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number876.4370
Classification Product Code
KQT  
Date Received06/23/1981
Decision Date 07/13/1981
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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