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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 K100520
Device Name NIPRO BIOHOLE NEEDLE WITH CAPICK SCAB REMOVER
Applicant
Nipro Medical Corporation
3150 NW 107th Ave.
Miami,  FL  33172
Applicant Contact JESSICA OSWALD
Correspondent
Nipro Medical Corporation
3150 NW 107th Ave.
Miami,  FL  33172
Correspondent Contact JESSICA OSWALD
Regulation Number876.5540
Classification Product Code
FIE  
Date Received02/23/2010
Decision Date 03/17/2010
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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