• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
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 Road; 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
-
-