MucoPEG
Saliva, Artificial
SunBio, Inc.
The following data is part of a premarket notification filed by Sunbio, Inc. with the FDA for Mucopeg.
Pre-market Notification Details
| Device ID | K190144 |
| 510k Number | K190144 |
| Device Name: | MucoPEG |
| Classification | Saliva, Artificial |
| Applicant | SunBio, Inc. 95 Sanbon-ro Gunpo-si, KR 15849 |
| Contact | Sun S. Kim |
| Correspondent | Stuart R. Goldman Emergo By UL 2500 Bee Cave Road; Bldg. 1, Suite 300 Austin, TX 78746 |
| Product Code | LFD |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-01-29 |
| Decision Date | 2019-11-05 |
Trademark Results [MucoPEG]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 MUCOPEG 87828257 not registered Live/Pending |
SUNBIO INC. 2018-03-09 |
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