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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name oral wound dressing
510(k) Number K183436
Device Name OraCure
Applicant
TBM Corporation
B-301, Gwangju High-tech Center, 313,
Cheomadangwagi-ro, Buk-gu
Gwangju,  KR 61008
Applicant Contact Jae-woong Jeong
Correspondent
KMC, Inc.
Room no. 904, 27, Digital-ro 27ga-gil, Guro-gu
Seoul,  KR 08375
Correspondent Contact Ryan Hwang
Classification Product Code
OLR  
Date Received12/11/2018
Decision Date 09/18/2019
Decision Substantially Equivalent (SESE)
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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