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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, urethral
510(k) Number K101900
Device Name HAKKI URINARY CATHETER; SIZE 14, 16, 18, 20, 22, 24, 26 FRENCH
Applicant
HAKKI MEDICAL TECHNOLOGIES, INC.
3851 62ND AVE. NORTH
SUITE A
PINELLAS PARK,  FL  33781
Applicant Contact ANDREW ENDAHL
Correspondent
HAKKI MEDICAL TECHNOLOGIES, INC.
3851 62ND AVE. NORTH
SUITE A
PINELLAS PARK,  FL  33781
Correspondent Contact ANDREW ENDAHL
Regulation Number876.5130
Classification Product Code
GBM  
Date Received07/07/2010
Decision Date 02/07/2011
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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