The following data is part of a premarket notification filed by Walgen Medical Innoventions with the FDA for Cement Fume Evacuator Tank & Filter.
| Device ID | K810542 |
| 510k Number | K810542 |
| Device Name: | CEMENT FUME EVACUATOR TANK & FILTER |
| Classification | Evacuator, Vapor, Cement Monomer |
| Applicant | WALGEN MEDICAL INNOVENTIONS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JDY |
| CFR Regulation Number | 888.4220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-02-27 |
| Decision Date | 1981-03-13 |