The following data is part of a premarket notification filed by Fci (france Chirurgie Instrumentation) with the FDA for Nunchaku.
Device ID | K161373 |
510k Number | K161373 |
Device Name: | Nunchaku |
Classification | Lacrimal Stents And Intubation Sets |
Applicant | FCI (FRANCE CHIRURGIE INSTRUMENTATION) 20-22 RUE LOUIS ARMAND Paris, FR 75015 |
Contact | Thierry Fetick |
Correspondent | Barbara S. Fant CLINICAL RESEARCH CONSULTANTS, INC. 3308 JEFFERSON AVE, UPPER LEVEL Cincinnati, OH 45220 |
Product Code | OKS |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2016-05-17 |
Decision Date | 2016-11-03 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
NUNCHAKU 87875492 5621699 Live/Registered |
SHENZHEN UWELL TECHNOLOGY CO., LTD. 2018-04-13 |
NUNCHAKU 87653057 not registered Dead/Abandoned |
SHENZHEN UWELL TECHNOLOGY CO., LTD 2017-10-20 |
NUNCHAKU 75767067 2531181 Dead/Cancelled |
MLC Limited Company 1999-08-03 |
NUNCHAKU 73709575 1589073 Dead/Cancelled |
LANDSBERG, MARCUS L. 1988-02-04 |