The following data is part of a premarket notification filed by Tuttnauer Usa Co. Ltd. with the FDA for Tuttnauer Elara-11 Pre-vacuum Tabletop Autoclave.
| Device ID | K090783 |
| 510k Number | K090783 |
| Device Name: | TUTTNAUER ELARA-11 PRE-VACUUM TABLETOP AUTOCLAVE |
| Classification | Sterilizer, Steam |
| Applicant | TUTTNAUER USA CO. LTD. 1700 K STREET, NW SUITE 300 Washington, DC 20006 |
| Contact | Theodore Sullivan |
| Correspondent | Theodore Sullivan TUTTNAUER USA CO. LTD. 1700 K STREET, NW SUITE 300 Washington, DC 20006 |
| Product Code | FLE |
| CFR Regulation Number | 880.6880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-03-23 |
| Decision Date | 2009-08-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290110640002 | K090783 | 000 |