The following data is part of a premarket notification filed by Ackrad Laboratories with the FDA for Trakefit Tracheostomy Tube Holder.
| Device ID | K872277 |
| 510k Number | K872277 |
| Device Name: | TRAKEFIT TRACHEOSTOMY TUBE HOLDER |
| Classification | Device, Fixation, Tracheal Tube |
| Applicant | ACKRAD LABORATORIES 70 JACKSON DR. Cranford, NJ 07016 |
| Contact | Bernard Ackerman,phd |
| Correspondent | Bernard Ackerman,phd ACKRAD LABORATORIES 70 JACKSON DR. Cranford, NJ 07016 |
| Product Code | CBH |
| CFR Regulation Number | 868.5770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-06-15 |
| Decision Date | 1987-07-21 |