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 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M84937620 | K834413 | 000 |
| M84932060 | K834413 | 000 |
| M84932080 | K834413 | 000 |
| M84932100 | K834413 | 000 |
| M84932120 | K834413 | 000 |
| M84932500 | K834413 | 000 |
| M84932540 | K834413 | 000 |
| M84932580 | K834413 | 000 |
| M84932600 | K834413 | 000 |
| M84932040 | K834413 | 000 |
| M84932020 | K834413 | 000 |
| M84931040 | K834413 | 000 |
| M84931060 | K834413 | 000 |
| M84931520 | K834413 | 000 |
| M84931560 | K834413 | 000 |
| M84931580 | K834413 | 000 |
| M84931800 | K834413 | 000 |
| M84931820 | K834413 | 000 |
| M84931840 | K834413 | 000 |
| M84932620 | K834413 | 000 |
| M84932640 | K834413 | 000 |
| M84937400 | K834413 | 000 |
| M84937420 | K834413 | 000 |
| M84937440 | K834413 | 000 |
| M84937520 | K834413 | 000 |
| M84937540 | K834413 | 000 |
| M84937560 | K834413 | 000 |
| M84937580 | K834413 | 000 |
| M84937600 | K834413 | 000 |
| M84937380 | K834413 | 000 |
| M84937360 | K834413 | 000 |
| M84932660 | K834413 | 000 |
| M84937080 | K834413 | 000 |
| M84937100 | K834413 | 000 |
| M84937120 | K834413 | 000 |
| M84937140 | K834413 | 000 |
| M84937160 | K834413 | 000 |
| M84937320 | K834413 | 000 |
| M84937340 | K834413 | 000 |
| M84931020 | K834413 | 000 |