The following data is part of a premarket notification filed by Saeyang Microtech Co., Ltd with the FDA for Endo E Class.
Device ID | K123608 |
510k Number | K123608 |
Device Name: | ENDO E CLASS |
Classification | Controller, Foot, Handpiece And Cord |
Applicant | SAEYANG MICROTECH CO., LTD 55 NORTHERN BLVD Great Neck, NY 11021 |
Contact | Jigar Shah |
Correspondent | Jigar Shah SAEYANG MICROTECH CO., LTD 55 NORTHERN BLVD Great Neck, NY 11021 |
Product Code | EBW |
CFR Regulation Number | 872.4200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2012-11-21 |
Decision Date | 2013-08-16 |
Summary: | summary |