The following data is part of a premarket notification filed by Anthogyr Sas with the FDA for Montblanc Surgical Contra-angle And Straight Handpiece.
Device ID | K111532 |
510k Number | K111532 |
Device Name: | MONTBLANC SURGICAL CONTRA-ANGLE AND STRAIGHT HANDPIECE |
Classification | Handpiece, Contra- And Right-angle Attachment, Dental |
Applicant | ANTHOGYR SAS 2237, AVENUE ANDRE LASQUIN Sallanches, FR 74700 |
Contact | Brayette Sabine |
Correspondent | Brayette Sabine ANTHOGYR SAS 2237, AVENUE ANDRE LASQUIN Sallanches, FR 74700 |
Product Code | EGS |
CFR Regulation Number | 872.4200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2011-06-03 |
Decision Date | 2011-10-07 |
Summary: | summary |