The following data is part of a premarket notification filed by Sauter Ag with the FDA for Belimed Steam Sterilizer, Model Top 5000.
| Device ID | K021223 |
| 510k Number | K021223 |
| Device Name: | BELIMED STEAM STERILIZER, MODEL TOP 5000 |
| Classification | Sterilizer, Steam |
| Applicant | SAUTER AG ZELGSTRASSE 8 Sulgen, CH Ch-8583 |
| Contact | Hans Stadler |
| Correspondent | Mark Job 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 | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2002-04-18 |
| Decision Date | 2002-06-26 |
| Summary: | summary |