The following data is part of a premarket notification filed by Keymed, Inc. with the FDA for Key Med Foreign Body Removal Tube.
| Device ID | K813325 |
| 510k Number | K813325 |
| Device Name: | KEY MED FOREIGN BODY REMOVAL TUBE |
| Classification | Endoscopic Access Overtube, Gastroenterology-urology |
| Applicant | KEYMED, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FED |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-11-24 |
| Decision Date | 1982-02-10 |