The following data is part of a premarket notification filed by Microdental, Inc. with the FDA for Micr02 Osa Device.
Device ID | K133683 |
510k Number | K133683 |
Device Name: | MICR02 OSA DEVICE |
Classification | Device, Anti-snoring |
Applicant | MICRODENTAL, INC. 5601 ARNOLD RD. Dublin, CA 94568 |
Contact | Laura Sheppard |
Correspondent | Laura Sheppard MICRODENTAL, INC. 5601 ARNOLD RD. Dublin, CA 94568 |
Product Code | LRK |
CFR Regulation Number | 872.5570 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2013-12-02 |
Decision Date | 2014-07-24 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00863039000423 | K133683 | 000 |
00863039000416 | K133683 | 000 |