Device Classification Name |
Laser, Comb, Hair
|
510(k) Number |
K151516 |
Device Name |
Capillus82 |
Applicant |
Capillus, LLC |
1715 NW 82ND AVENUE |
MIAMI,
FL
33126
|
|
Applicant Contact |
PATRICIA SCHNOOR |
Correspondent |
Capillus, LLC |
1715 NW 82ND AVENUE |
MIAMI,
FL
33126
|
|
Correspondent Contact |
PATRICIA SCHNOOR |
Regulation Number | 890.5500
|
Classification Product Code |
|
Date Received | 06/05/2015 |
Decision Date | 08/21/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Physical Medicine
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|