The following data is part of a premarket notification filed by Tuttnauer Usa Co. Ltd. with the FDA for Pre-vacuum Autoclave With Steam Generator And Vertical Sliding Door, Models 4472 Ep-1v And 5596 Ep-1v.
| Device ID | K032192 |
| 510k Number | K032192 |
| Device Name: | PRE-VACUUM AUTOCLAVE WITH STEAM GENERATOR AND VERTICAL SLIDING DOOR, MODELS 4472 EP-1V AND 5596 EP-1V |
| Classification | Sterilizer, Steam |
| Applicant | TUTTNAUER USA CO. LTD. 1776 K STREET, N.W. SUITE 800 Washington, DC 20006 -7910 |
| Contact | Mark M Yacura |
| Correspondent | Mark M Yacura TUTTNAUER USA CO. LTD. 1776 K STREET, N.W. SUITE 800 Washington, DC 20006 -7910 |
| Product Code | FLE |
| CFR Regulation Number | 880.6880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-07-17 |
| Decision Date | 2004-08-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290110640248 | K032192 | 000 |
| 07290110640231 | K032192 | 000 |
| 07290110640224 | K032192 | 000 |
| 07290110640217 | K032192 | 000 |
| 07290110640200 | K032192 | 000 |
| 07290110640194 | K032192 | 000 |
| 07290110640415 | K032192 | 000 |
| 07290110640668 | K032192 | 000 |