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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 K063368
Device Name NIPRO BIOHOLE NEEDLE
Applicant
NIPRO MEDICAL CORP.
3150 NW 107 AVE..
MIAMI,  FL  33172
Applicant Contact JESSICA OSWALD
Correspondent
NIPRO MEDICAL CORP.
3150 NW 107 AVE..
MIAMI,  FL  33172
Correspondent Contact JESSICA OSWALD
Regulation Number876.5540
Classification Product Code
FIE  
Date Received11/07/2006
Decision Date 02/05/2007
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
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