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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Conduction, Anesthetic
510(k) Number K122661
Device Name VITAL 5 RELEAF CATHETER
Applicant
Vital 5
570 Research Park Way
Suite 102
North Logan,  UT  84341
Applicant Contact T. WADE FALLIN
Correspondent
Vital 5
570 Research Park Way
Suite 102
North Logan,  UT  84341
Correspondent Contact T. WADE FALLIN
Regulation Number868.5120
Classification Product Code
BSO  
Subsequent Product Code
GCY  
Date Received08/31/2012
Decision Date 02/27/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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