The following data is part of a premarket notification filed by Ben Venue Laboratories, Inc. with the FDA for Ethylene Oxide Gas Steriliza Sys Ii.
| Device ID | K833457 |
| 510k Number | K833457 |
| Device Name: | ETHYLENE OXIDE GAS STERILIZA SYS II |
| Classification | Sterilizer, Ethylene-oxide Gas |
| Applicant | BEN VENUE LABORATORIES, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | FLF |
| CFR Regulation Number | 880.6860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-10-05 |
| Decision Date | 1983-12-29 |