The following data is part of a premarket notification filed by Stackhouse Assoc. with the FDA for Biovac: Lfa Laser Fume (smoke) Evacuatio.
| Device ID | K790877 |
| 510k Number | K790877 |
| Device Name: | BIOVAC: LFA LASER FUME (SMOKE) EVACUATIO |
| Classification | Evacuator, Vapor, Cement Monomer |
| Applicant | STACKHOUSE ASSOC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | JDY |
| CFR Regulation Number | 888.4220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-05-07 |
| Decision Date | 1979-05-23 |