The following data is part of a premarket notification filed by Coast Medical Corp. with the FDA for Nasopharyngeal Airway.
| Device ID | K921353 |
| 510k Number | K921353 |
| Device Name: | NASOPHARYNGEAL AIRWAY |
| Classification | Airway, Nasopharyngeal |
| Applicant | COAST MEDICAL CORP. 1060 NORTH BATAVIA UNIT H Orange, CA 92667 |
| Contact | Doyglas R Mongeon |
| Correspondent | Doyglas R Mongeon COAST MEDICAL CORP. 1060 NORTH BATAVIA UNIT H Orange, CA 92667 |
| Product Code | BTQ |
| CFR Regulation Number | 868.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-03-19 |
| Decision Date | 1992-06-11 |