The following data is part of a premarket notification filed by Leana Orders, Inc. with the FDA for Grivamax Hair Growth System.
Device ID | K171895 |
510k Number | K171895 |
Device Name: | Grivamax Hair Growth System |
Classification | Laser, Comb, Hair |
Applicant | Leana Orders, Inc. 431 Travis Avenue Staten Island, NY 10314 -6150 |
Contact | Leonid Krits |
Correspondent | Raymond R. Blanche NST Consulting, LLC 641 Shunpike Road Chatham, NJ 07928 |
Product Code | OAP |
CFR Regulation Number | 890.5500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-06-26 |
Decision Date | 2017-08-22 |
Summary: | summary |