The following data is part of a premarket notification filed by The Lynn Terrell Co. with the FDA for Simvac.
| Device ID | K811991 |
| 510k Number | K811991 |
| Device Name: | SIMVAC |
| Classification | Attachment, Intermittent Mandatory Ventilation (imv) |
| Applicant | THE LYNN TERRELL CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | CBO |
| CFR Regulation Number | 868.5955 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-07-13 |
| Decision Date | 1981-08-12 |