The following data is part of a premarket notification filed by Wavelight Laser Technologie Ag with the FDA for Mydon C.
Device ID | K040384 |
510k Number | K040384 |
Device Name: | MYDON C |
Classification | Powered Laser Surgical Instrument |
Applicant | WAVELIGHT LASER TECHNOLOGIE AG 5 TIMBER LANE North Reading, MA 01864 |
Contact | Maureen O'connell |
Correspondent | Maureen O'connell WAVELIGHT LASER TECHNOLOGIE AG 5 TIMBER LANE North Reading, MA 01864 |
Product Code | GEX |
CFR Regulation Number | 878.4810 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2004-02-17 |
Decision Date | 2004-05-14 |
Summary: | summary |