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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Hemodialysis, Implanted
510(k) Number K981365
Device Name MAHURKAR 13.5 FR CUFFED CATHETER WITH CURVED EXTENSIONS
Applicant
Sherwood Medical Co.
3303 Monte Villa Pkwy.
Bothell,  WA  98021
Applicant Contact ROSEMARY HARRY
Correspondent
Sherwood Medical Co.
3303 Monte Villa Pkwy.
Bothell,  WA  98021
Correspondent Contact ROSEMARY HARRY
Regulation Number876.5540
Classification Product Code
MSD  
Date Received04/15/1998
Decision Date 11/25/1998
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
Predetermined Change
Control Plan Authorized		 No
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