The following data is part of a premarket notification filed by Fls Medical Products, Inc. with the FDA for Nasopharyngeal Airway-robertazzi Style.
| Device ID | K831476 |
| 510k Number | K831476 |
| Device Name: | NASOPHARYNGEAL AIRWAY-ROBERTAZZI STYLE |
| Classification | Airway, Nasopharyngeal |
| Applicant | FLS MEDICAL PRODUCTS, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | BTQ |
| CFR Regulation Number | 868.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-05-09 |
| Decision Date | 1983-06-10 |