The following data is part of a premarket notification filed by M.i.tech Co., Ltd. with the FDA for Hanarostent Esophagus Asymmetric (ccc).
| Device ID | K213251 |
| 510k Number | K213251 |
| Device Name: | HANAROSTENT Esophagus Asymmetric (CCC) |
| Classification | Prosthesis, Esophageal |
| Applicant | M.I.Tech Co., Ltd. 174, Habuk 2-gil, Jinwi-myeon Pyeongtaek-si, KR 17706 |
| Contact | Sunyoung Jo |
| Correspondent | Heidi Busz Namsa 00 Highway 169 South, Suite 500 Minneapolis, MN 55426 |
| Product Code | ESW |
| CFR Regulation Number | 878.3610 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-09-30 |
| Decision Date | 2021-11-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08806367096029 | K213251 | 000 |
| 08806367044549 | K213251 | 000 |
| 08806367044532 | K213251 | 000 |
| 08806367044525 | K213251 | 000 |
| 08806367044518 | K213251 | 000 |
| 08806367044501 | K213251 | 000 |
| 08806367044495 | K213251 | 000 |
| 08806367044440 | K213251 | 000 |
| 08806367044433 | K213251 | 000 |
| 08806367044426 | K213251 | 000 |
| 08806367044419 | K213251 | 000 |
| 08806367044402 | K213251 | 000 |
| 08806367043351 | K213251 | 000 |
| 08806367020376 | K213251 | 000 |
| 08806367020369 | K213251 | 000 |
| 08806367044556 | K213251 | 000 |
| 08806367044563 | K213251 | 000 |
| 08806367096012 | K213251 | 000 |
| 08806367096005 | K213251 | 000 |
| 08806367095992 | K213251 | 000 |
| 08806367095985 | K213251 | 000 |
| 08806367095978 | K213251 | 000 |
| 08806367095961 | K213251 | 000 |
| 08806367044778 | K213251 | 000 |
| 08806367044761 | K213251 | 000 |
| 08806367044754 | K213251 | 000 |
| 08806367044747 | K213251 | 000 |
| 08806367044730 | K213251 | 000 |
| 08806367044723 | K213251 | 000 |
| 08806367044716 | K213251 | 000 |
| 08806367044709 | K213251 | 000 |
| 08806367020352 | K213251 | 000 |