The following data is part of a premarket notification filed by Garrett Medical Products with the FDA for Trach Tie, Ventilator Tubing Holder.
| Device ID | K942016 |
| 510k Number | K942016 |
| Device Name: | TRACH TIE, VENTILATOR TUBING HOLDER |
| Classification | Device, Fixation, Tracheal Tube |
| Applicant | GARRETT MEDICAL PRODUCTS 203 VIA SERENA RD. Rancho Santa Margarita, CA 92688 |
| Contact | John D Calebaugh |
| Correspondent | John D Calebaugh GARRETT MEDICAL PRODUCTS 203 VIA SERENA RD. Rancho Santa Margarita, CA 92688 |
| Product Code | CBH |
| CFR Regulation Number | 868.5770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-04-26 |
| Decision Date | 1994-05-24 |