The following data is part of a premarket notification filed by Neomed, Inc. with the FDA for Neomed Urinary Catheter.
| Device ID | K072997 |
| 510k Number | K072997 |
| Device Name: | NEOMED URINARY CATHETER |
| Classification | Catheter, Straight |
| Applicant | NEOMED, INC. 717 LAKEGLEN DR. Suwanee, GA 30024 |
| Contact | Penny Northcutt |
| Correspondent | Penny Northcutt NEOMED, INC. 717 LAKEGLEN DR. Suwanee, GA 30024 |
| Product Code | EZD |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-10-24 |
| Decision Date | 2007-12-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10350770003211 | K072997 | 000 |
| 10350770003204 | K072997 | 000 |
| 10350770003198 | K072997 | 000 |
| 10350770003181 | K072997 | 000 |