The following data is part of a premarket notification filed by Eastmed Enterprises Inc. with the FDA for Robertazzi Nasopharyngeal Airway.
| Device ID | K903618 |
| 510k Number | K903618 |
| Device Name: | ROBERTAZZI NASOPHARYNGEAL AIRWAY |
| Classification | Airway, Nasopharyngeal |
| Applicant | EASTMED ENTERPRISES INC. 5 PEMBURY COURT Marlton, NJ 08053 |
| Contact | Rathin Putatunda |
| Correspondent | Rathin Putatunda EASTMED ENTERPRISES INC. 5 PEMBURY COURT Marlton, NJ 08053 |
| Product Code | BTQ |
| CFR Regulation Number | 868.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-08-07 |
| Decision Date | 1991-01-08 |