The following data is part of a premarket notification filed by Tuttnauer Co. Ltd. with the FDA for Ehs Series Table Top Autoclave, Models 2540 And 3870.
| Device ID | K003470 |
| 510k Number | K003470 |
| Device Name: | EHS SERIES TABLE TOP AUTOCLAVE, MODELS 2540 AND 3870 |
| Classification | Sterilizer, Steam |
| Applicant | TUTTNAUER CO. LTD. 1776 K ST. N.W. SUITE 800 Washington, DC 20006 -2365 |
| Contact | Mark Yacura |
| Correspondent | Mark Yacura TUTTNAUER CO. LTD. 1776 K ST. N.W. SUITE 800 Washington, DC 20006 -2365 |
| Product Code | FLE |
| CFR Regulation Number | 880.6880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-11-08 |
| Decision Date | 2001-02-20 |