The following data is part of a premarket notification filed by Novoxel Ltd. with the FDA for Tixel System.
Device ID | K202988 |
510k Number | K202988 |
Device Name: | Tixel System |
Classification | Electrosurgical, Cutting & Coagulation & Accessories |
Applicant | Novoxel Ltd. 43 Hamelaha St. Netanya, IL 4250573 |
Contact | Ronen Shavit |
Correspondent | Janice M. Hogan Hogan Lovells, US LLP 1735 Market Street, Floor 23 Philadelphia, PA 19103 |
Product Code | GEI |
CFR Regulation Number | 878.4400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2020-09-30 |
Decision Date | 2021-02-25 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
07290117524022 | K202988 | 000 |
07290117524015 | K202988 | 000 |
07290117524008 | K202988 | 000 |
07290117524060 | K202988 | 000 |
07290117524053 | K202988 | 000 |
07290117524046 | K202988 | 000 |