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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Saliva, Artificial
510(k) Number K190144
Device Name MucoPEG
Applicant
Sunbio, Inc.
95 Sanbon-Ro
Gunpo-Si,  KR 15849
Applicant Contact Sun S. Kim
Correspondent
Emergo by UL
2500 Bee Cave Rd.; Bldg. 1, Suite 300
Austin,  TX  78746
Correspondent Contact Stuart R. Goldman
Classification Product Code
LFD  
Date Received01/29/2019
Decision Date 11/05/2019
Decision Substantially Equivalent (SESE)
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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