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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, retention type, balloon
510(k) Number K921561
Device Name YSI MODELS 4400 FOLEY CATHETER TEMPERATURE PROBES
Applicant
YSIS, INC
1725 BRANNUM LN.
YELLOW SPRINGS,  OH  45387 -0279
Applicant Contact FRED BREIDT
Correspondent
YSIS, INC
1725 BRANNUM LN.
YELLOW SPRINGS,  OH  45387 -0279
Correspondent Contact FRED BREIDT
Regulation Number876.5130
Classification Product Code
EZL  
Date Received04/01/1992
Decision Date 11/23/1992
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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