• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
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
-
-