The following data is part of a premarket notification filed by Medeon Biodesign, Inc. with the FDA for Abclose - Port Site Closure Device.
| Device ID | K193652 |
| 510k Number | K193652 |
| Device Name: | AbClose - Port Site Closure Device |
| Classification | Endoscopic Tissue Approximation Device |
| 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 | OCW |
| Subsequent Product Code | GCJ |
| Subsequent Product Code | HCF |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-12-30 |
| Decision Date | 2020-03-26 |