The following data is part of a premarket notification filed by C.r. Bard, Inc. with the FDA for Bard Eliminator Pet Balloon Dilators.
| Device ID | K033936 |
| 510k Number | K033936 |
| Device Name: | BARD ELIMINATOR PET BALLOON DILATORS |
| Classification | Dilator, Esophageal |
| Applicant | C.R. BARD, INC. 129 CONCORD ROAD BUILDING 3 Billerica, MA 01821 |
| Contact | Michael A Patz |
| Correspondent | Michael A Patz C.R. BARD, INC. 129 CONCORD ROAD BUILDING 3 Billerica, MA 01821 |
| Product Code | KNQ |
| CFR Regulation Number | 876.5365 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-12-19 |
| Decision Date | 2004-01-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10653405052623 | K033936 | 000 |
| 20653405052583 | K033936 | 000 |
| 10653405052517 | K033936 | 000 |
| 20653405052477 | K033936 | 000 |
| 10653405052616 | K033936 | 000 |
| 10653405052609 | K033936 | 000 |