The following data is part of a premarket notification filed by Ackrad Laboratories with the FDA for Comfit Plus Endotracheal Tube Holder & Bite Block.
| Device ID | K850309 |
| 510k Number | K850309 |
| Device Name: | COMFIT PLUS ENDOTRACHEAL TUBE HOLDER & BITE BLOCK |
| Classification | Support, Breathing Tube |
| Applicant | ACKRAD LABORATORIES 70 JACKSON DR. Cranford, NJ 07016 |
| Contact | Bernard Ackerman |
| Correspondent | Bernard Ackerman ACKRAD LABORATORIES 70 JACKSON DR. Cranford, NJ 07016 |
| Product Code | JAY |
| CFR Regulation Number | 868.5280 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-01-25 |
| Decision Date | 1985-02-14 |