The following data is part of a premarket notification filed by American Sterilizer Co. with the FDA for Sterilizer, Eagle 2000.
| Device ID | K781684 |
| 510k Number | K781684 |
| Device Name: | STERILIZER, EAGLE 2000 |
| Classification | Sterilizer, Steam |
| Applicant | AMERICAN STERILIZER CO. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | FLE |
| CFR Regulation Number | 880.6880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-10-02 |
| Decision Date | 1978-10-24 |