The following data is part of a premarket notification filed by Meridian Ag with the FDA for Merilas 532a.
Device ID | K072823 |
510k Number | K072823 |
Device Name: | MERILAS 532A |
Classification | Laser, Ophthalmic |
Applicant | MERIDIAN AG 13 RED FOX LN. Littleton, CO 80127 |
Contact | Kevin Walls |
Correspondent | Kevin Walls MERIDIAN AG 13 RED FOX LN. Littleton, CO 80127 |
Product Code | HQF |
CFR Regulation Number | 886.4390 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-10-02 |
Decision Date | 2007-12-14 |
Summary: | summary |