The following data is part of a premarket notification filed by Sunshine International Group, Inc. with the FDA for Ulceloocin Oral Ulcer Patch.
| Device ID | K070842 |
| 510k Number | K070842 |
| Device Name: | ULCELOOCIN ORAL ULCER PATCH |
| Classification | Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic |
| Applicant | SUNSHINE INTERNATIONAL GROUP, INC. 1333 BROADWAY SUITE 1222 New York, NY 10018 |
| Contact | Liping He |
| Correspondent | Liping He SUNSHINE INTERNATIONAL GROUP, INC. 1333 BROADWAY SUITE 1222 New York, NY 10018 |
| Product Code | MGQ |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-03-27 |
| Decision Date | 2007-06-07 |
| Summary: | summary |