The following data is part of a premarket notification filed by M.i. Tech Co., Ltd. with the FDA for Hanarostent Esophagus (ccc).
| Device ID | K093537 |
| 510k Number | K093537 |
| Device Name: | HANAROSTENT ESOPHAGUS (CCC) |
| Classification | Prosthesis, Esophageal |
| Applicant | M.I. TECH CO., LTD. 49 CANDLEWOOD WAY Buena Park, CA 90621 |
| Contact | Brandon Choi |
| Correspondent | Brandon Choi M.I. TECH CO., LTD. 49 CANDLEWOOD WAY Buena Park, CA 90621 |
| Product Code | ESW |
| CFR Regulation Number | 878.3610 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-11-16 |
| Decision Date | 2010-06-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08806367058249 | K093537 | 000 |
| 08806367004222 | K093537 | 000 |
| 08806367004215 | K093537 | 000 |
| 08806367004208 | K093537 | 000 |
| 08806367004192 | K093537 | 000 |
| 08806367004185 | K093537 | 000 |
| 08806367004178 | K093537 | 000 |
| 08806367004161 | K093537 | 000 |
| 08806367004147 | K093537 | 000 |
| 08806367021816 | K093537 | 000 |
| 08806367021823 | K093537 | 000 |
| 08806367046796 | K093537 | 000 |
| 08806367040350 | K093537 | 000 |
| 08806367024961 | K093537 | 000 |
| 08806367024824 | K093537 | 000 |
| 08806367024817 | K093537 | 000 |
| 08806367024800 | K093537 | 000 |
| 08806367024794 | K093537 | 000 |
| 08806367021830 | K093537 | 000 |
| 08806367004130 | K093537 | 000 |