The following data is part of a premarket notification filed by Micron Corp. with the FDA for Quick Jet M.
Device ID | K133170 |
510k Number | K133170 |
Device Name: | QUICK JET M |
Classification | Handpiece, Air-powered, Dental |
Applicant | MICRON CORP. 1-34-14 HIGASHIYUKIGAYA Ota-ku, Tokyo, JP 145-0065 |
Contact | Takashi Terui |
Correspondent | Takashi Terui MICRON CORP. 1-34-14 HIGASHIYUKIGAYA Ota-ku, Tokyo, JP 145-0065 |
Product Code | EFB |
CFR Regulation Number | 872.4200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2013-10-17 |
Decision Date | 2014-03-28 |
Summary: | summary |