The following data is part of a premarket notification filed by Medeon Biodesign, Inc with the FDA for Laparoscope Lens Shield Device (lens).
| Device ID | K192891 |
| 510k Number | K192891 |
| Device Name: | Laparoscope Lens Shield Device (LENS) |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | Medeon Biodesign, Inc 7F, 116 Hougang St., Taipei, TW 11170 |
| Contact | Tsung-yu Hsieh |
| Correspondent | Tsung-yu Hsieh Medeon Biodesign, Inc 7F, 116 Hougang St., Taipei, TW 11170 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-10-10 |
| Decision Date | 2019-11-07 |