The following data is part of a premarket notification filed by Micro-mega Societe Anonyme with the FDA for J Single Use Head And Jd Reusable Handle.
Device ID | K950555 |
510k Number | K950555 |
Device Name: | J SINGLE USE HEAD AND JD REUSABLE HANDLE |
Classification | Handpiece, Contra- And Right-angle Attachment, Dental |
Applicant | MICRO-MEGA SOCIETE ANONYME 5-12 RUE DU TUNNEL Cedex Besancon, FR 25006 |
Contact | Jm Badoz |
Correspondent | Jm Badoz MICRO-MEGA SOCIETE ANONYME 5-12 RUE DU TUNNEL Cedex Besancon, FR 25006 |
Product Code | EGS |
CFR Regulation Number | 872.4200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-02-07 |
Decision Date | 1995-12-28 |