The following data is part of a premarket notification filed by Tuttnauer Co. Ltd. with the FDA for Tuttnauer Ez Plus Series Electronic Tabletop Autoclaves.
| Device ID | K111736 |
| 510k Number | K111736 |
| Device Name: | TUTTNAUER EZ PLUS SERIES ELECTRONIC TABLETOP AUTOCLAVES |
| Classification | Sterilizer, Steam |
| Applicant | TUTTNAUER CO. LTD. 1700 K STREET NW SUITE 300 Washington, DC 20006 |
| Contact | Theodore Sullivan |
| Correspondent | Theodore Sullivan TUTTNAUER 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 | 2011-06-20 |
| Decision Date | 2011-12-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290110640040 | K111736 | 000 |
| 07290110640033 | K111736 | 000 |
| 07290110640026 | K111736 | 000 |
| 07290110640019 | K111736 | 000 |