The following data is part of a premarket notification filed by Teleflex Medical, Inc. with the FDA for Pilling Esophageal Bougies.
| Device ID | K133439 |
| 510k Number | K133439 |
| Device Name: | PILLING ESOPHAGEAL BOUGIES |
| Classification | Bougie, Esophageal, And Gastrointestinal, Gastro-urology |
| Applicant | Teleflex Medical, Inc. 2917 WECK DR. Research Triangle Park, NC 27709 |
| Contact | Holly Kornegay |
| Correspondent | Holly Kornegay Teleflex Medical, Inc. 2917 WECK DR. Research Triangle Park, NC 27709 |
| Product Code | FAT |
| CFR Regulation Number | 876.5365 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-11-12 |
| Decision Date | 2014-06-16 |
| Summary: | summary |