The following data is part of a premarket notification filed by Pilling Co. with the FDA for Jackson Esophageal Bougie, X-ray Opaque.
| Device ID | K800623 |
| 510k Number | K800623 |
| Device Name: | JACKSON ESOPHAGEAL BOUGIE, X-RAY OPAQUE |
| Classification | Bougie, Esophageal, Ent |
| Applicant | PILLING CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KCD |
| CFR Regulation Number | 874.4420 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-03-19 |
| Decision Date | 1980-04-24 |