The following data is part of a premarket notification filed by Tuttnauer Usa Co. Ltd. with the FDA for Tuttnauer Electronic Autoclave, Models E, Ea, Ek, Eka, Ep.
| Device ID | K993856 |
| 510k Number | K993856 |
| Device Name: | TUTTNAUER ELECTRONIC AUTOCLAVE, MODELS E, EA, EK, EKA, EP |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-11-15 |
| Decision Date | 2001-02-09 |
| Summary: | summary |