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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
Applicant Contact FRED BREIDT
Correspondent
Ysis, Inc.
1725 Brannum Ln.
Yellow Springs,  OH  45387
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
Predetermined Change
Control Plan Authorized		 No
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