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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Irrigation, Urological
510(k) Number K882295
Device Name FILLING VOLUME OPTION
Applicant
ERIS MEDICAL TECHNOLOGY
1308 SPRINGFIELD AVE.
NEW PROVIDENCE,  NJ  07974
Applicant Contact DAVID SUGGS
Correspondent
ERIS MEDICAL TECHNOLOGY
1308 SPRINGFIELD AVE.
NEW PROVIDENCE,  NJ  07974
Correspondent Contact DAVID SUGGS
Regulation Number876.5130
Classification Product Code
LJH  
Date Received06/02/1988
Decision Date 09/13/1988
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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