The following data is part of a premarket notification filed by Amsco Co. with the FDA for Eagle 2000 Sterilizer Series Gas/aera.
| Device ID | K832945 |
| 510k Number | K832945 |
| Device Name: | EAGLE 2000 STERILIZER SERIES GAS/AERA |
| Classification | Sterilizer, Ethylene-oxide Gas |
| Applicant | AMSCO CO. 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 | 1983-08-30 |
| Decision Date | 1983-10-19 |