The following data is part of a premarket notification filed by Blake Medical, Inc. with the FDA for Blake Medical Breathing Tube Support.
| Device ID | K902604 |
| 510k Number | K902604 |
| Device Name: | BLAKE MEDICAL BREATHING TUBE SUPPORT |
| Classification | Device, Fixation, Tracheal Tube |
| Applicant | BLAKE MEDICAL, INC. 2803 CARMICHEAL DR. Tifton, GA 31794 |
| Contact | Mark B Lott |
| Correspondent | Mark B Lott BLAKE MEDICAL, INC. 2803 CARMICHEAL DR. Tifton, GA 31794 |
| Product Code | CBH |
| CFR Regulation Number | 868.5770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-06-12 |
| Decision Date | 1990-10-02 |