The following data is part of a premarket notification filed by Inmed Corp. with the FDA for Sterile Nasopharyngeal Airway.
| Device ID | K853162 |
| 510k Number | K853162 |
| Device Name: | STERILE NASOPHARYNGEAL AIRWAY |
| Classification | Airway, Nasopharyngeal |
| Applicant | INMED CORP. 3030-B HOLCOMB BRIDGE RD. Norcross, GA 30071 |
| Contact | Flo Becker |
| Correspondent | Flo Becker INMED CORP. 3030-B HOLCOMB BRIDGE RD. Norcross, GA 30071 |
| Product Code | BTQ |
| CFR Regulation Number | 868.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-07-30 |
| Decision Date | 1985-08-06 |