The following data is part of a premarket notification filed by Enbio Group Ag with the FDA for Enbio S.
Device ID | K210279 |
510k Number | K210279 |
Device Name: | Enbio S |
Classification | Sterilizer, Steam |
Applicant | Enbio Group AG Eichengasse 3 Oensingen, CH Ch-4702 |
Contact | Lukasz Rogowski |
Correspondent | Lukasz Rogowski Enbio Group AG Eichengasse 3 Oensingen, CH Ch-4702 |
Product Code | FLE |
CFR Regulation Number | 880.6880 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2021-02-01 |
Decision Date | 2021-10-29 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
ENBIO S 97169643 not registered Live/Pending |
ENBIO TECHNOLOGY Sp. z o.o. 2021-12-13 |
ENBIO S 97169643 not registered Live/Pending |
ENBIO GROUP AG 2021-12-13 |