The following data is part of a premarket notification filed by Sauter Ag with the FDA for Belimed Steam Sterilizer Top 5000, Series 4 - 8.
| Device ID | K033538 |
| 510k Number | K033538 |
| Device Name: | BELIMED STEAM STERILIZER TOP 5000, SERIES 4 - 8 |
| Classification | Sterilizer, Steam |
| Applicant | SAUTER AG ZELGSTRASSE 8 Sulgen Tg, CH Ch-8583 |
| Contact | Hans Stadler |
| Correspondent | Stefan Preiss TUV AMERICA, INC. 1775 OLD HIGHWAY 8 New Brighton, MN 55112 -1891 |
| Product Code | FLE |
| CFR Regulation Number | 880.6880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2003-11-10 |
| Decision Date | 2004-02-02 |
| Summary: | summary |