The following data is part of a premarket notification filed by Ventlab Corp. with the FDA for Et-restraint Cat. # Er 4000.
| Device ID | K900236 |
| 510k Number | K900236 |
| Device Name: | ET-RESTRAINT CAT. # ER 4000 |
| Classification | Device, Fixation, Tracheal Tube |
| Applicant | VENTLAB CORP. 221 GRACIE PLACE Hackensack, NJ 07601 |
| Contact | Gregory Lau |
| Correspondent | Gregory Lau VENTLAB CORP. 221 GRACIE PLACE Hackensack, NJ 07601 |
| Product Code | CBH |
| CFR Regulation Number | 868.5770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-01-17 |
| Decision Date | 1990-02-02 |