The following data is part of a premarket notification filed by Byrd Medical Devices, Inc. with the FDA for Multi-purpose Medical Tube Holder.
| Device ID | K963365 |
| 510k Number | K963365 |
| Device Name: | MULTI-PURPOSE MEDICAL TUBE HOLDER |
| Classification | Device, Intravascular Catheter Securement |
| Applicant | BYRD MEDICAL DEVICES, INC. 111 CENTER PARK DR., SUITE 200 Knoxville, TN 37922 |
| Contact | Tim Byrd |
| Correspondent | Tim Byrd BYRD MEDICAL DEVICES, INC. 111 CENTER PARK DR., SUITE 200 Knoxville, TN 37922 |
| Product Code | KMK |
| CFR Regulation Number | 880.5210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-08-27 |
| Decision Date | 1996-10-11 |