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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 K982970
Device Name MRI'S ALL SILICONE IRRIGATION 3-WAY FOLEY CATHETER
Applicant
MRI MANUFACTURING AND RESEARCH, INC.
3234 ELLA LN.
NEW PORT RICHEY,  FL  34655
Applicant Contact ED RANSON
Correspondent
MRI MANUFACTURING AND RESEARCH, INC.
3234 ELLA LN.
NEW PORT RICHEY,  FL  34655
Correspondent Contact ED RANSON
Regulation Number876.5130
Classification Product Code
EZL  
Date Received08/25/1998
Decision Date 10/28/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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