The following data is part of a premarket notification filed by Inmed Corp. with the FDA for Ultra External Catheter.
| Device ID | K844801 |
| 510k Number | K844801 |
| Device Name: | ULTRA EXTERNAL CATHETER |
| Classification | Collector, Urine, (and Accessories) For Indwelling Catheter |
| Applicant | INMED CORP. 3030-B HOLCOMB BRIDGE RD. Norcross, GA 30071 |
| Contact | Flo Becker |
| Correspondent | Flo Becker INMED CORP. 3030-B HOLCOMB BRIDGE RD. Norcross, GA 30071 |
| Product Code | KNX |
| CFR Regulation Number | 876.5250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-12-11 |
| Decision Date | 1985-01-15 |