The following data is part of a premarket notification filed by Cyden Limited with the FDA for Ipulse, Quadra Q4 Platinum Series, Model(s) 1200+series 2, 1300 Series 2, Q4 Series 2.
Device ID | K071883 |
510k Number | K071883 |
Device Name: | IPULSE, QUADRA Q4 PLATINUM SERIES, MODEL(S) 1200+SERIES 2, 1300 SERIES 2, Q4 SERIES 2 |
Classification | Powered Laser Surgical Instrument |
Applicant | CYDEN LIMITED TECHNIUM 1, KINGS ROAD Swansea, Wales, GB Sa1 8ph |
Contact | Michael Kiernan |
Correspondent | Michael Kiernan CYDEN LIMITED TECHNIUM 1, KINGS ROAD Swansea, Wales, GB Sa1 8ph |
Product Code | GEX |
CFR Regulation Number | 878.4810 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-07-09 |
Decision Date | 2008-01-23 |