The following data is part of a premarket notification filed by Ackrad Laboratories with the FDA for Ackrad N-do Vage Tube.
| Device ID | K813607 |
| 510k Number | K813607 |
| Device Name: | ACKRAD N-DO VAGE TUBE |
| Classification | Lavage, Jet |
| Applicant | ACKRAD LABORATORIES 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FQH |
| CFR Regulation Number | 880.5475 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-12-29 |
| Decision Date | 1982-02-05 |