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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name tunneled catheter remover
510(k) Number K122263
Device Name 14.5-16.0 FRENCH CUFFED CATHETER REMOVAL DEVICE, SYMMETRY SURGICAL SINGEL USE
Applicant
SYMMETRY MEDICAL
3034 OWEN DRIVE
ANTIOCH,  TN  37013
Applicant Contact HANNAH FOLEY
Correspondent
SYMMETRY MEDICAL
3034 OWEN DRIVE
ANTIOCH,  TN  37013
Correspondent Contact HANNAH FOLEY
Regulation Number880.5970
Classification Product Code
ODY  
Date Received07/27/2012
Decision Date 09/28/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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