The following data is part of a premarket notification filed by Tuttnauer Ltd. with the FDA for Tuttnauer Horizontal Models:4472,5596,6690,66120,69120 And 69180 Autoclaves.
| Device ID | K181456 |
| 510k Number | K181456 |
| Device Name: | Tuttnauer Horizontal Models:4472,5596,6690,66120,69120 And 69180 Autoclaves |
| Classification | Sterilizer, Steam |
| Applicant | Tuttnauer Ltd. Har Tuv B Industrial Park Beit Shemesh, IL |
| Contact | Aline Peled |
| Correspondent | Theodore Sullivan Quarles & Brady 1701 K Street 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 | 2018-06-04 |
| Decision Date | 2019-07-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290110640590 | K181456 | 000 |
| 07290110640750 | K181456 | 000 |
| 07290110640453 | K181456 | 000 |
| 07290110640460 | K181456 | 000 |
| 07290110640477 | K181456 | 000 |
| 07290110640484 | K181456 | 000 |
| 07290110640491 | K181456 | 000 |
| 07290110640507 | K181456 | 000 |
| 07290110640514 | K181456 | 000 |
| 07290110640521 | K181456 | 000 |
| 07290110640538 | K181456 | 000 |
| 07290110640545 | K181456 | 000 |
| 07290110640552 | K181456 | 000 |
| 07290110640569 | K181456 | 000 |
| 07290110640576 | K181456 | 000 |
| 07290110640583 | K181456 | 000 |
| 07290110640743 | K181456 | 000 |