The following data is part of a premarket notification filed by Hobbs Medical, Inc. with the FDA for Dilation Balloon Catheter.
| Device ID | K834413 |
| 510k Number | K834413 |
| Device Name: | DILATION BALLOON CATHETER |
| Classification | Stents, Drains And Dilators For The Biliary Ducts |
| Applicant | HOBBS MEDICAL, INC. 497 N. MAIN ST. Palmer, MA 01069 |
| Contact | Eamonn P Hobbs |
| Correspondent | Eamonn P Hobbs HOBBS MEDICAL, INC. P.O. Box 272 497 N. Main Street Palmer, MA 01069 |
| Product Code | FGE |
| CFR Regulation Number | 876.5010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-12-15 |
| Decision Date | 1984-05-22 |