Device Classification Name |
epilator, high frequency, needle-type
|
510(k) Number |
K864869 |
Device Name |
HR-5000 ELECTROSURGICAL DEVICE |
Applicant |
IME CO. LTD. |
1775 PENNSYLVANIA AVENUE, N.W. |
WASHINGTON,
DC
20006
|
|
Applicant Contact |
KEVIN G MCANANEY |
Correspondent |
IME CO. LTD. |
1775 PENNSYLVANIA AVENUE, N.W. |
WASHINGTON,
DC
20006
|
|
Correspondent Contact |
KEVIN G MCANANEY |
Regulation Number | 878.5350
|
Classification Product Code |
|
Date Received | 12/12/1986 |
Decision Date | 05/19/1987 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|