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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 K082882
Device Name A.V. FISTULA BLUNT NEEDLE SET
Applicant
Jms North America Corp.
55 Northern Blvd., Suite 200
Great Neck,  NY  11021
Applicant Contact MARIA F GRIFFIN
Correspondent
Jms North America Corp.
55 Northern Blvd., Suite 200
Great Neck,  NY  11021
Correspondent Contact MARIA F GRIFFIN
Regulation Number876.5540
Classification Product Code
FIE  
Date Received09/30/2008
Decision Date 01/21/2009
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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