Device Classification Name |
brush, dermabrasion, powered
|
510(k) Number |
K963204 |
Device Name |
DMS-1000C DERMOABRADER |
Applicant |
AESTHETIC LASERS, INC. |
528 COLLEGE PKWY., SUITE C-1 |
ANNAPOLIS,
MD
21401
|
|
Applicant Contact |
FRED DE JACMA |
Correspondent |
AESTHETIC LASERS, INC. |
528 COLLEGE PKWY., SUITE C-1 |
ANNAPOLIS,
MD
21401
|
|
Correspondent Contact |
FRED DE JACMA |
Regulation Number | 878.4820
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 08/15/1996 |
Decision Date | 12/09/1996 |
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
|
|
|