The following data is part of a premarket notification filed by Amsco Intl., Inc. with the FDA for Eagle Century Steam Sterilizer.
| Device ID | K964332 |
| 510k Number | K964332 |
| Device Name: | EAGLE CENTURY STEAM STERILIZER |
| Classification | Sterilizer, Steam |
| Applicant | AMSCO INTL., INC. 2424 W 23RD STREET-AMSCO-620 Erie, PA 16514 |
| Contact | Paul Zamecnik |
| Correspondent | Paul Zamecnik AMSCO INTL., INC. 2424 W 23RD STREET-AMSCO-620 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 | 1996-10-30 |
| Decision Date | 1998-06-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00724995151843 | K964332 | 000 |
| 00724995150778 | K964332 | 000 |
| 00724995150761 | K964332 | 000 |
| 00724995150754 | K964332 | 000 |
| 00724995150747 | K964332 | 000 |
| 00724995150730 | K964332 | 000 |
| 00724995150723 | K964332 | 000 |
| 00724995150716 | K964332 | 000 |
| 00724995150709 | K964332 | 000 |
| 00724995150693 | K964332 | 000 |
| 00724995150686 | K964332 | 000 |
| 00724995150679 | K964332 | 000 |
| 00724995150662 | K964332 | 000 |
| 00724995150785 | K964332 | 000 |
| 00724995150792 | K964332 | 000 |
| 00724995151836 | K964332 | 000 |
| 00724995151829 | K964332 | 000 |
| 00724995151812 | K964332 | 000 |
| 00724995151805 | K964332 | 000 |
| 00724995151799 | K964332 | 000 |
| 00724995151782 | K964332 | 000 |
| 00724995151775 | K964332 | 000 |
| 00724995151768 | K964332 | 000 |
| 00724995151751 | K964332 | 000 |
| 00724995150822 | K964332 | 000 |
| 00724995150815 | K964332 | 000 |
| 00724995150808 | K964332 | 000 |
| 00724995150655 | K964332 | 000 |