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 | K170103 |
| 510k Number | K170103 |
| Device Name: | Laparoscope Lens Shield Device (LENS) |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | Medeon Biodesign, Inc 7F, 116, HouGang St, Taipei, TW 11170 |
| Contact | Greta Chang |
| Correspondent | Greta Chang 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 | 2017-01-12 |
| Decision Date | 2017-02-16 |
| Summary: | summary |