The following data is part of a premarket notification filed by Health Care Contracts, Inc. with the FDA for Hci Tube Stabilizer.
| Device ID | K942529 |
| 510k Number | K942529 |
| Device Name: | HCI TUBE STABILIZER |
| Classification | Device, Fixation, Tracheal Tube |
| Applicant | HEALTH CARE CONTRACTS, INC. 5405 BANDERE RD. SUITE 116 San Antonio, TX 78238 |
| Contact | Dean Wenrich |
| Correspondent | Dean Wenrich HEALTH CARE CONTRACTS, INC. 5405 BANDERE RD. SUITE 116 San Antonio, TX 78238 |
| Product Code | CBH |
| CFR Regulation Number | 868.5770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-05-27 |
| Decision Date | 1995-06-14 |