The following data is part of a premarket notification filed by Sauter Ag with the FDA for Belimed Steam Sterilizer Mst-h.
Device ID | K141879 |
510k Number | K141879 |
Device Name: | BELIMED STEAM STERILIZER MST-H |
Classification | Sterilizer, Steam |
Applicant | SAUTER AG ZELGSTRASSE 8 Sulgen Tg, CH Ch-8583 |
Contact | Michael Hari |
Correspondent | Michael Hari SAUTER AG ZELGSTRASSE 8 Sulgen Tg, CH Ch-8583 |
Product Code | FLE |
CFR Regulation Number | 880.6880 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Abbreviated |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-07-11 |
Decision Date | 2015-06-17 |
Summary: | summary |