The following data is part of a premarket notification filed by Mpowrx Health And Wellness Products 2012 Inc with the FDA for Mpowrx Snoring Solution (also Known As Good Morning Snore Solution).
Device ID | K193239 |
510k Number | K193239 |
Device Name: | MPowRx Snoring Solution (also Known As Good Morning Snore Solution) |
Classification | Device, Anti-snoring |
Applicant | MPowRx Health And Wellness Products 2012 Inc # 510 3553-31 St. NW Calgary, CA T2l2k7 |
Contact | Nancy Markley |
Correspondent | Ray Kelly Arazy Group Consultants Inc. 3422 Leonardo Lane New Smyrna Beach, FL 32168 |
Product Code | LRK |
CFR Regulation Number | 872.5570 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2019-11-25 |
Decision Date | 2020-01-03 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00627843257127 | K193239 | 000 |