The following data is part of a premarket notification filed by Fortune Medical Instrument Corp. with the FDA for All Silicone 2-way & 3-way Foly Balloon Catheter And Nelaton Catheter.
| Device ID | K980919 |
| 510k Number | K980919 |
| Device Name: | ALL SILICONE 2-WAY & 3-WAY FOLY BALLOON CATHETER AND NELATON CATHETER |
| Classification | Catheter, Retention Type, Balloon |
| Applicant | FORTUNE MEDICAL INSTRUMENT CORP. 3722 AVE. SAUSALITO Irvine, CA 92606 |
| Contact | Karen U Salinas |
| Correspondent | Karen U Salinas FORTUNE MEDICAL INSTRUMENT CORP. 3722 AVE. SAUSALITO Irvine, CA 92606 |
| Product Code | EZL |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-03-11 |
| Decision Date | 1998-03-31 |