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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 K771860
Device Name FOLHY CATHETER
Applicant
POLYSIL, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
POLYSIL, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number876.5130
Classification Product Code
EZL  
Date Received09/30/1977
Decision Date 10/18/1977
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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