The following data is part of a premarket notification filed by M.i. Tech Co., Ltd. with the FDA for Hanarostent Biliary (nnn).
| Device ID | K111149 |
| 510k Number | K111149 |
| Device Name: | HANAROSTENT BILIARY (NNN) |
| Classification | Stents, Drains And Dilators For The Biliary Ducts |
| Applicant | M.I. TECH CO., LTD. 1733 CANTON LANE Marietta, GA 30062 |
| Contact | Paul Sumner |
| Correspondent | Paul Sumner M.I. TECH CO., LTD. 1733 CANTON LANE Marietta, GA 30062 |
| Product Code | FGE |
| CFR Regulation Number | 876.5010 [🔎] |
| Decision | Se - With Limitations (SESU) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-04-25 |
| Decision Date | 2011-12-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08806367047199 | K111149 | 000 |
| 08806367017628 | K111149 | 000 |
| 08806367017611 | K111149 | 000 |
| 08806367017604 | K111149 | 000 |
| 08806367017598 | K111149 | 000 |
| 08806367017581 | K111149 | 000 |
| 08806367017574 | K111149 | 000 |
| 08806367017567 | K111149 | 000 |
| 08806367017468 | K111149 | 000 |
| 08806367017444 | K111149 | 000 |
| 08806367017437 | K111149 | 000 |
| 08806367017420 | K111149 | 000 |
| 08806367017413 | K111149 | 000 |
| 08806367017406 | K111149 | 000 |
| 08806367017390 | K111149 | 000 |
| 08806367017642 | K111149 | 000 |
| 08806367047021 | K111149 | 000 |
| 08806367047182 | K111149 | 000 |
| 08806367047151 | K111149 | 000 |
| 08806367047144 | K111149 | 000 |
| 08806367047137 | K111149 | 000 |
| 08806367047120 | K111149 | 000 |
| 08806367047113 | K111149 | 000 |
| 08806367047106 | K111149 | 000 |
| 08806367047090 | K111149 | 000 |
| 08806367047083 | K111149 | 000 |
| 08806367047076 | K111149 | 000 |
| 08806367047069 | K111149 | 000 |
| 08806367047052 | K111149 | 000 |
| 08806367047045 | K111149 | 000 |
| 08806367047038 | K111149 | 000 |
| 08806367017383 | K111149 | 000 |