The following data is part of a premarket notification filed by Trophy Skin, Inc. with the FDA for Rejuvatonemd.
Device ID | K152199 |
510k Number | K152199 |
Device Name: | RejuvatoneMD |
Classification | Stimulator, Transcutaneous Electrical, Aesthetic Purposes |
Applicant | TROPHY SKIN, INC. 4372 KENMARE TRAIL Frisco, TX 75034 |
Contact | Imran Karim |
Correspondent | Sue Anthoney-dewet AEGIS REGULATORY, INC. 2424 DEMPSTER DRIVE Coralville, IA 52241 |
Product Code | NFO |
CFR Regulation Number | 882.5890 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2015-08-06 |
Decision Date | 2016-03-23 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00851561006105 | K152199 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
REJUVATONEMD 86096250 5418457 Live/Registered |
Trophy Skin, Inc. 2013-10-20 |