Device Classification Name |
laser, comb, hair
|
510(k) Number |
K141567 |
Device Name |
IGROW - II HAIR GROWTH SYSTEM, IGROW HAIR GROWTH SYSTEM |
Applicant |
APIRA SCIENCE, INC. |
641 SHUNPIKE RD, STE 311 |
CHATHAM,
NJ
07928
|
|
Applicant Contact |
RAYMOND R BLANCHE |
Correspondent |
APIRA SCIENCE, INC. |
641 SHUNPIKE RD, STE 311 |
CHATHAM,
NJ
07928
|
|
Correspondent Contact |
RAYMOND R BLANCHE |
Regulation Number | 890.5500
|
Classification Product Code |
|
Date Received | 06/12/2014 |
Decision Date | 08/21/2014 |
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
|
|
|