Device Classification Name |
laser, comb, hair
|
510(k) Number |
K171895 |
Device Name |
Grivamax Hair Growth System |
Applicant |
Leana Orders, Inc. |
431 Travis Avenue |
Staten Island,
NY
10314 -6150
|
|
Applicant Contact |
Leonid Krits |
Correspondent |
NST Consulting, LLC |
641 Shunpike Road |
Chatham,
NJ
07928
|
|
Correspondent Contact |
Raymond R. Blanche |
Regulation Number | 890.5500
|
Classification Product Code |
|
Date Received | 06/26/2017 |
Decision Date | 08/22/2017 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Physical Medicine
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|