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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 K063721
Device Name NIPRO SAFETOUCH II GAMMA
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 Received12/15/2006
Decision Date 01/12/2007
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
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