The following data is part of a premarket notification filed by Dryden Corp. with the FDA for Nasopharyngeal Airway-robertazzi.
| Device ID | K850644 |
| 510k Number | K850644 |
| Device Name: | NASOPHARYNGEAL AIRWAY-ROBERTAZZI |
| Classification | Airway, Nasopharyngeal |
| Applicant | DRYDEN CORP. 5707 PARK PLAZA COURT Indianapolis, IN 46220 |
| Contact | Paul E Dryden |
| Correspondent | Paul E Dryden DRYDEN CORP. 5707 PARK PLAZA COURT Indianapolis, IN 46220 |
| Product Code | BTQ |
| CFR Regulation Number | 868.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-02-19 |
| Decision Date | 1985-03-21 |