The following data is part of a premarket notification filed by Dacomed Corp. with the FDA for Eska Multistage Esophageal Bougie.
| Device ID | K843186 |
| 510k Number | K843186 |
| Device Name: | ESKA MULTISTAGE ESOPHAGEAL BOUGIE |
| Classification | Bougie, Esophageal, And Gastrointestinal, Gastro-urology |
| Applicant | DACOMED CORP. 1701 E. 79TH ST., STE. 17 Minneapolis, MN 55425 |
| Contact | Margot T Young |
| Correspondent | Margot T Young DACOMED CORP. 1701 E. 79TH ST., STE. 17 Minneapolis, MN 55425 |
| Product Code | FAT |
| CFR Regulation Number | 876.5365 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-08-13 |
| Decision Date | 1985-01-18 |