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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Straight
510(k) Number K062444
Device Name HI-SLIP AND HI-SLIP PLUS SINGLE USE HYDROPHILIC URINARY CATHETERS AND KIT
Applicant
OASIS MEDIKAL URUNLER KIMYA SANAYI VE TIC A.S.
208 BARRINGTON OVERLOOK
DURHAM,  NC  27703
Applicant Contact CHARLES H KYPER
Correspondent
OASIS MEDIKAL URUNLER KIMYA SANAYI VE TIC A.S.
208 BARRINGTON OVERLOOK
DURHAM,  NC  27703
Correspondent Contact CHARLES H KYPER
Regulation Number876.5130
Classification Product Code
EZD  
Date Received08/21/2006
Decision Date 02/22/2007
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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