The following data is part of a premarket notification filed by Hobbs Medical, Inc. with the FDA for Et/rt Papillotome.
| Device ID | K860593 |
| 510k Number | K860593 |
| Device Name: | ET/RT PAPILLOTOME |
| Classification | Unit, Electrosurgical, Endoscopic (with Or Without Accessories) |
| Applicant | HOBBS MEDICAL, INC. P.O. BOX 46 SPRING STREET Stafford Springs, CT 06076 |
| Contact | Steven G Richter |
| Correspondent | Steven G Richter HOBBS MEDICAL, INC. P.O. BOX 46 SPRING STREET Stafford Springs, CT 06076 |
| Product Code | KNS |
| CFR Regulation Number | 876.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-02-19 |
| Decision Date | 1986-07-22 |