The following data is part of a premarket notification filed by Quanta System, S.p.a. with the FDA for Litho.
Device ID | K141101 |
510k Number | K141101 |
Device Name: | LITHO |
Classification | Powered Laser Surgical Instrument |
Applicant | QUANTA SYSTEM, S.P.A. VIA IV NOVEMBRE,116 Solbiate Olona, IT 21058 |
Contact | Maurizio Bianchi |
Correspondent | Maurizio Bianchi QUANTA SYSTEM, S.P.A. VIA IV NOVEMBRE,116 Solbiate Olona, IT 21058 |
Product Code | GEX |
CFR Regulation Number | 878.4810 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-04-29 |
Decision Date | 2014-08-08 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
LITHO 90821109 not registered Live/Pending |
KaJ Labs Foundation 2021-07-09 |
LITHO 88236399 not registered Live/Pending |
Purple Tambourine Limited 2018-12-20 |