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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscopic Guidewire, Gastroenterology-Urology
510(k) Number K060034
Device Name NIPRO HYDROPHILIC GUIDEWIRE FOR UROLOGICAL & LAPAROSCOPIC USE
Applicant
NIPRO MEDICAL CORPORATION
1384 COPPERFIELD COURT
LEXINGTON,  KY  40514
Applicant Contact KAELYN B HADLEY
Correspondent
NIPRO MEDICAL CORPORATION
1384 COPPERFIELD COURT
LEXINGTON,  KY  40514
Correspondent Contact KAELYN B HADLEY
Regulation Number876.1500
Classification Product Code
OCY  
Date Received01/05/2006
Decision Date 02/28/2006
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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