The following data is part of a premarket notification filed by Medline Industries, Inc. with the FDA for Medline Red Rubber Urethral Catheter.
| Device ID | K092250 |
| 510k Number | K092250 |
| Device Name: | MEDLINE RED RUBBER URETHRAL CATHETER |
| Classification | Catheter, Ureteral, Gastro-urology |
| Applicant | MEDLINE INDUSTRIES, INC. ONE MEDLINE PLACE Mundelein, IL 60060 |
| Contact | Matt Clausen |
| Correspondent | Matt Clausen MEDLINE INDUSTRIES, INC. ONE MEDLINE PLACE Mundelein, IL 60060 |
| Product Code | EYB |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-07-28 |
| Decision Date | 2010-01-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00616784507033 | K092250 | 000 |
| 00616784506937 | K092250 | 000 |
| 00616784506838 | K092250 | 000 |
| 00616784506739 | K092250 | 000 |
| 00616784506630 | K092250 | 000 |
| 00616784506531 | K092250 | 000 |
| 00616784506432 | K092250 | 000 |
| 00616784506333 | K092250 | 000 |
| 00616784506234 | K092250 | 000 |