The following data is part of a premarket notification filed by Cleveland Medical Supply & Services with the FDA for Colorectal Dilator.
| Device ID | K830354 |
| 510k Number | K830354 |
| Device Name: | COLORECTAL DILATOR |
| Classification | Dilator, Rectal |
| Applicant | CLEVELAND MEDICAL SUPPLY & SERVICES 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FFP |
| CFR Regulation Number | 876.5450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-02-03 |
| Decision Date | 1983-05-27 |