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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name negative pressure wound therapy powered suction pump
510(k) Number K122490
Device Name KULAVAC
Original Applicant
163-3 samsung-dong
seoul,  KR 135-715
Original Contact jungeun im
Regulation Number878.4780
Classification Product Code
Date Received08/15/2012
Decision Date 11/13/2013
Decision substantially equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No