The following data is part of a premarket notification filed by Mill-rose Laboratory with the FDA for Papillotome Product.
| Device ID | K802444 |
| 510k Number | K802444 |
| Device Name: | PAPILLOTOME PRODUCT |
| Classification | Unit, Electrosurgical, Endoscopic (with Or Without Accessories) |
| Applicant | MILL-ROSE LABORATORY 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KNS |
| CFR Regulation Number | 876.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-10-07 |
| Decision Date | 1980-10-23 |