The following data is part of a premarket notification filed by Eastmed Enterprises Inc. with the FDA for Endotracheal Tube Stylet.
| Device ID | K921128 |
| 510k Number | K921128 |
| Device Name: | ENDOTRACHEAL TUBE STYLET |
| Classification | Stylet, Tracheal Tube |
| 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 | BSR |
| CFR Regulation Number | 868.5790 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-03-10 |
| Decision Date | 1992-06-02 |