The following data is part of a premarket notification filed by 3t Medical Systems, Llc. with the FDA for 3t/sewoon Temperature Sensing Foley Catheters.
| Device ID | K022287 |
| 510k Number | K022287 |
| Device Name: | 3T/SEWOON TEMPERATURE SENSING FOLEY CATHETERS |
| Classification | Catheter, Retention Type, Balloon |
| Applicant | 3T MEDICAL SYSTEMS, LLC. 12553 S. WAMBLEE VALLEY RD. Conifer, CO 80433 -6204 |
| Contact | Robert P Eaton |
| Correspondent | Robert P Eaton 3T MEDICAL SYSTEMS, LLC. 12553 S. WAMBLEE VALLEY RD. Conifer, CO 80433 -6204 |
| Product Code | EZL |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-07-15 |
| Decision Date | 2002-09-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08806369403801 | K022287 | 000 |
| 08806369403788 | K022287 | 000 |
| 08806369403764 | K022287 | 000 |
| 08806369403740 | K022287 | 000 |
| 08806369403726 | K022287 | 000 |
| 08806369403702 | K022287 | 000 |