The following data is part of a premarket notification filed by Eastmed Enterprises Inc. with the FDA for Airways (guedel, Berman & Nasopharyngeal Types).
| Device ID | K890342 |
| 510k Number | K890342 |
| Device Name: | AIRWAYS (GUEDEL, BERMAN & NASOPHARYNGEAL TYPES) |
| Classification | Tube, Tracheostomy (w/wo Connector) |
| 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 | BTO |
| CFR Regulation Number | 868.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-01-23 |
| Decision Date | 1989-04-27 |