The following data is part of a premarket notification filed by C.r. Bard, Inc. with the FDA for Eliminator Balloon Dilator.
| Device ID | K940965 |
| 510k Number | K940965 |
| Device Name: | ELIMINATOR BALLOON DILATOR |
| Classification | Stents, Drains And Dilators For The Biliary Ducts |
| Applicant | C.R. BARD, INC. 200 AMES POND DR. Tewksbury, MA 01876 |
| Contact | John A Delucia |
| Correspondent | John A Delucia C.R. BARD, INC. 200 AMES POND DR. Tewksbury, MA 01876 |
| Product Code | FGE |
| CFR Regulation Number | 876.5010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-03-02 |
| Decision Date | 1994-05-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10653405052616 | K940965 | 000 |
| 20653405052422 | K940965 | 000 |
| 20653405052439 | K940965 | 000 |
| 20653405052446 | K940965 | 000 |
| 20653405052453 | K940965 | 000 |
| 20653405052460 | K940965 | 000 |
| 10653405052494 | K940965 | 000 |
| 10653405052500 | K940965 | 000 |
| 20653405052521 | K940965 | 000 |
| 20653405052538 | K940965 | 000 |
| 20653405052545 | K940965 | 000 |
| 20653405052552 | K940965 | 000 |
| 20653405052569 | K940965 | 000 |
| 20653405052576 | K940965 | 000 |
| 10653405052593 | K940965 | 000 |
| 10653405052609 | K940965 | 000 |
| 20653405052415 | K940965 | 000 |