The following data is part of a premarket notification filed by Tuttnauer Usa Co. Ltd. with the FDA for Pre-vacuum Tabletop Autoclave.
| Device ID | K143311 |
| 510k Number | K143311 |
| Device Name: | Pre-vacuum Tabletop Autoclave |
| Classification | Sterilizer, Steam |
| Applicant | TUTTNAUER USA CO. LTD. 25 POWER DR. Hauppauge, NY 11788 |
| Contact | Robert Basile |
| Correspondent | Theodore Sullivan Buchanan, Ingersoll, & Rooney PC 1700 K Street NW 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 | 2014-11-18 |
| Decision Date | 2015-01-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290110640187 | K143311 | 000 |
| 07290110640439 | K143311 | 000 |
| 07290110640446 | K143311 | 000 |
| 07290110640712 | K143311 | 000 |
| 07290110640705 | K143311 | 000 |
| 07290110640736 | K143311 | 000 |
| 07290110640729 | K143311 | 000 |
| 07290110640651 | K143311 | 000 |
| 07290110640644 | K143311 | 000 |