The following data is part of a premarket notification filed by Micro-mega Societe Anonyme with the FDA for Apex Pointer+; Measruing Cable, Hook, Lip Clip, Touch Probe (accessories).
Device ID | K103123 |
510k Number | K103123 |
Device Name: | APEX POINTER+; MEASRUING CABLE, HOOK, LIP CLIP, TOUCH PROBE (ACCESSORIES) |
Classification | Locator, Root Apex |
Applicant | MICRO-MEGA SOCIETE ANONYME 5-12 RUE DU TUNNEL Cedex Besancon, FR 25006 |
Contact | Conche Philippe |
Correspondent | Conche Philippe MICRO-MEGA SOCIETE ANONYME 5-12 RUE DU TUNNEL Cedex Besancon, FR 25006 |
Product Code | LQY |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2010-10-21 |
Decision Date | 2011-03-10 |
Summary: | summary |