The following data is part of a premarket notification filed by Amsco Co. with the FDA for Eagle 3000 Sds.
| Device ID | K912471 |
| 510k Number | K912471 |
| Device Name: | EAGLE 3000 SDS |
| Classification | Sterilizer, Steam |
| Applicant | AMSCO CO. 2424 WEST 23RD ST. Erie, PA 16514 |
| Contact | Michael J Zmuda |
| Correspondent | Michael J Zmuda AMSCO CO. 2424 WEST 23RD ST. Erie, PA 16514 |
| Product Code | FLE |
| CFR Regulation Number | 880.6880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-06-04 |
| Decision Date | 1992-06-26 |