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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 K123751
Device Name LOFRIC SENSE
Applicant
WELLSPECT HEALTHCARE
12264 EL CAMINO REAL
SUITE 400
SAN DIEGO,  CA  92130
Applicant Contact Allison C Komiyama
Correspondent
WELLSPECT HEALTHCARE
12264 EL CAMINO REAL
SUITE 400
SAN DIEGO,  CA  92130
Correspondent Contact Allison C Komiyama
Regulation Number876.5130
Classification Product Code
EZD  
Date Received12/06/2012
Decision Date 02/28/2013
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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