The following data is part of a premarket notification filed by Fortune Medical Instrument Corp. with the FDA for All Silicone Supra-pubia Catheter, Models 4880/4890.
| Device ID | K014002 |
| 510k Number | K014002 |
| Device Name: | ALL SILICONE SUPRA-PUBIA CATHETER, MODELS 4880/4890 |
| Classification | Catheter, Suprapubic (and Accessories) |
| Applicant | FORTUNE MEDICAL INSTRUMENT CORP. 12-9, LIN 5, MAO-CHANG VILLAGE SAN-CHIH HSIANG Taipei Hsien, TW 252 |
| Contact | Abe Wang |
| Correspondent | Abe Wang FORTUNE MEDICAL INSTRUMENT CORP. 12-9, LIN 5, MAO-CHANG VILLAGE SAN-CHIH HSIANG Taipei Hsien, TW 252 |
| Product Code | KOB |
| CFR Regulation Number | 876.5090 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-12-04 |
| Decision Date | 2002-03-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04711182606978 | K014002 | 000 |
| 04710961937531 | K014002 | 000 |
| 04710961934257 | K014002 | 000 |
| 04710961934240 | K014002 | 000 |
| 04710961934233 | K014002 | 000 |
| 04710961934226 | K014002 | 000 |
| 04710961934219 | K014002 | 000 |
| 04710961934202 | K014002 | 000 |
| 04710961934196 | K014002 | 000 |
| 04710961934189 | K014002 | 000 |
| 04710961934172 | K014002 | 000 |
| 04710961934165 | K014002 | 000 |
| 04710961934158 | K014002 | 000 |
| 04710961934141 | K014002 | 000 |
| 04710961934134 | K014002 | 000 |
| 04710961934127 | K014002 | 000 |
| 04710961937548 | K014002 | 000 |
| 04710961937555 | K014002 | 000 |
| 04711182606961 | K014002 | 000 |
| 04710961937692 | K014002 | 000 |
| 04710961937685 | K014002 | 000 |
| 04710961937678 | K014002 | 000 |
| 04710961937661 | K014002 | 000 |
| 04710961937654 | K014002 | 000 |
| 04710961937647 | K014002 | 000 |
| 04710961937630 | K014002 | 000 |
| 04710961937623 | K014002 | 000 |
| 04710961937616 | K014002 | 000 |
| 04710961937609 | K014002 | 000 |
| 04710961937593 | K014002 | 000 |
| 04710961937586 | K014002 | 000 |
| 04710961937579 | K014002 | 000 |
| 04710961937562 | K014002 | 000 |
| 04710961933472 | K014002 | 000 |