The following data is part of a premarket notification filed by Diemolding Corp. with the FDA for Cuff-mate 2 Endotracheal Cuff Inflator & Monitor.
| Device ID | K902114 |
| 510k Number | K902114 |
| Device Name: | CUFF-MATE 2 ENDOTRACHEAL CUFF INFLATOR & MONITOR |
| Classification | Cuff, Tracheal Tube, Inflatable |
| Applicant | DIEMOLDING CORP. 125 RASBACH ST. Canastota, NY 13032 |
| Contact | Jean Wallace |
| Correspondent | Jean Wallace DIEMOLDING CORP. 125 RASBACH ST. Canastota, NY 13032 |
| Product Code | BSK |
| CFR Regulation Number | 868.5750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-05-11 |
| Decision Date | 1990-07-18 |