The following data is part of a premarket notification filed by Belimed Sauter Ag with the FDA for Belimed Steam Sterilizer Model Top 5000 Series 24.
| Device ID | K072087 |
| 510k Number | K072087 |
| Device Name: | BELIMED STEAM STERILIZER MODEL TOP 5000 SERIES 24 |
| Classification | Sterilizer, Steam |
| Applicant | BELIMED SAUTER AG ZELGSTRASSE 8 Sulgen (tg), CH Ch-8583 |
| Contact | Hans Stadler |
| Correspondent | Stefan Preiss TUV SUD AMERICA INC. 1775 OLD HIGHWAY 8 NW 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 | 2007-07-30 |
| Decision Date | 2007-10-05 |
| Summary: | summary |