The following data is part of a premarket notification filed by Fortune Medical Instrument Corp. with the FDA for Fortune All Silicone Stomach (gastric) Tubes, Model 2020.
| Device ID | K022112 |
| 510k Number | K022112 |
| Device Name: | FORTUNE ALL SILICONE STOMACH (GASTRIC) TUBES, MODEL 2020 |
| Classification | Tubes, Gastrointestinal (and Accessories) |
| Applicant | FORTUNE MEDICAL INSTRUMENT CORP. 12-9, LIN 5, MAO-CHANG VILLAGE SAN-CHIH HSIANG Taipei Hsien, TW 252 |
| Contact | Jessica Chan |
| Correspondent | Jessica Chan FORTUNE MEDICAL INSTRUMENT CORP. 12-9, LIN 5, MAO-CHANG VILLAGE SAN-CHIH HSIANG Taipei Hsien, TW 252 |
| Product Code | KNT |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-06-28 |
| Decision Date | 2003-04-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04711182605407 | K022112 | 000 |
| 04710961936343 | K022112 | 000 |
| 04710961936350 | K022112 | 000 |
| 04710961936367 | K022112 | 000 |
| 04710961936374 | K022112 | 000 |
| 04710961936381 | K022112 | 000 |
| 04710961936398 | K022112 | 000 |
| 04710961936404 | K022112 | 000 |
| 04711182605391 | K022112 | 000 |
| 04710961936336 | K022112 | 000 |