The following data is part of a premarket notification filed by Meridian Ag with the FDA for Microrupter V.
Device ID | K023045 |
510k Number | K023045 |
Device Name: | MICRORUPTER V |
Classification | Laser, Neodymium:yag, Ophthalmic For Posterior Capsulotomy And Cutting Pupilla |
Applicant | MERIDIAN AG BIERIGUTSTRASSE 7 Thun, Bern, CH 3608 |
Contact | Kurt Frey |
Correspondent | Mark Job TUV AMERICA, INC. 1775 OLD HIGHWAY 8 New Brighton, MN 55112 -1891 |
Product Code | LXS |
CFR Regulation Number | 886.4392 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | Yes |
Combination Product | No |
Date Received | 2002-09-12 |
Decision Date | 2002-09-26 |
Summary: | summary |