The following data is part of a premarket notification filed by Ackrad Laboratories with the FDA for Ackrad Oral Suction Tube.
| Device ID | K854320 |
| 510k Number | K854320 |
| Device Name: | ACKRAD ORAL SUCTION TUBE |
| Classification | Catheters, Suction, Tracheobronchial |
| 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 | BSY |
| CFR Regulation Number | 868.6810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-10-28 |
| Decision Date | 1986-01-10 |