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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
Original Applicant
VITAL 5
570 research park way
suite 102
north logan,  UT  84341
Original 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
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