The following data is part of a premarket notification filed by Fortune Medical Instrument Corp. with the FDA for Fortune Silicone Vacuum Suction, Model #1300.
| Device ID | K021193 |
| 510k Number | K021193 |
| Device Name: | FORTUNE SILICONE VACUUM SUCTION, MODEL #1300 |
| Classification | Extractor, Vacuum, Fetal |
| Applicant | FORTUNE MEDICAL INSTRUMENT CORP. 12-9, LIN 5, MAO-CHANG VILLAGE SAN-CHIH HSIANG Taipei Hsien, TW 252 |
| Contact | Taipei Hsien |
| Correspondent | Taipei Hsien FORTUNE MEDICAL INSTRUMENT CORP. 12-9, LIN 5, MAO-CHANG VILLAGE SAN-CHIH HSIANG Taipei Hsien, TW 252 |
| Product Code | HDB |
| CFR Regulation Number | 884.4340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-04-15 |
| Decision Date | 2003-02-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04711182604004 | K021193 | 000 |
| 04710961930013 | K021193 | 000 |
| 04710961930006 | K021193 | 000 |