The following data is part of a premarket notification filed by Inmed Corp. with the FDA for Foam Helmet - Use W/esophageal Tampona.
| Device ID | K832859 |
| 510k Number | K832859 |
| Device Name: | FOAM HELMET - USE W/ESOPHAGEAL TAMPONA |
| Classification | Tubes, Gastrointestinal (and Accessories) |
| Applicant | INMED CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KNT |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-08-23 |
| Decision Date | 1983-11-14 |