The following data is part of a premarket notification filed by Narco Scientific with the FDA for Gottschalk Nasostat Slim Line, Adult/sm..
| Device ID | K811496 |
| 510k Number | K811496 |
| Device Name: | GOTTSCHALK NASOSTAT SLIM LINE, ADULT/SM. |
| Classification | Balloon, Epistaxis |
| Applicant | NARCO SCIENTIFIC 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | EMX |
| CFR Regulation Number | 874.4100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-05-27 |
| Decision Date | 1981-06-16 |