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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 K093637
Device Name JMS BLUNT A. V. FISTULA NEEDLE SET WITH SITE PREPARATION TOOL MODEL 820-5300, 820-6300 AND 820-7300
Applicant
Jms North America Corp.
1468 Harwell Ave.,
Crofton,  MD  21114
Applicant Contact E J SMITH
Correspondent
Jms North America Corp.
1468 Harwell Ave.,
Crofton,  MD  21114
Correspondent Contact E J SMITH
Regulation Number876.5540
Classification Product Code
FIE  
Date Received11/24/2009
Decision Date 02/09/2010
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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