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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Needle, Fistula
510(k) Number K110157
Device Name SYSLOC MINI V3
Applicant
JMS NORTH AMERICA CORPORATION
1468 HARWELL AVE.
CROFTON,  MD  21114
Applicant Contact E. J SMITH
Correspondent
JMS NORTH AMERICA CORPORATION
1468 HARWELL AVE.
CROFTON,  MD  21114
Correspondent Contact E. J SMITH
Regulation Number876.5540
Classification Product Code
FIE  
Date Received01/19/2011
Decision Date 02/11/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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