The following data is part of a premarket notification filed by Keymed, Inc. with the FDA for Split Colon Stiffening Tube.
| Device ID | K830247 |
| 510k Number | K830247 |
| Device Name: | SPLIT COLON STIFFENING TUBE |
| Classification | Endoscopic Access Overtube, Gastroenterology-urology |
| Applicant | KEYMED, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | FED |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-01-25 |
| Decision Date | 1983-03-15 |