The following data is part of a premarket notification filed by American Sterilizer Co. with the FDA for The Eagle 3017 100% Ethylene Oxide Sterilizer.
| Device ID | K931872 |
| 510k Number | K931872 |
| Device Name: | THE EAGLE 3017 100% ETHYLENE OXIDE STERILIZER |
| Classification | Sterilizer, Ethylene-oxide Gas |
| Applicant | AMERICAN STERILIZER CO. 2424 WEST 23RD ST. P.O. BOX 620 Erie, PA 16514 |
| Contact | Michael J Zmuda |
| Correspondent | Michael J Zmuda AMERICAN STERILIZER CO. 2424 WEST 23RD ST. P.O. BOX 620 Erie, PA 16514 |
| Product Code | FLF |
| CFR Regulation Number | 880.6860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-04-14 |
| Decision Date | 1994-02-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00724995152017 | K931872 | 000 |
| 50724995010336 | K931872 | 000 |