Device Classification Name |
powered laser surgical instrument
|
510(k) Number |
K010715 |
Device Name |
AL-40 |
Applicant |
DDC TECHNOLOGIES, INC. |
2980 WAVERLY AVE. |
OCEANSIDE,
NY
11572
|
|
Applicant Contact |
DMITRY DONSKOY |
Correspondent |
DDC TECHNOLOGIES, INC. |
2980 WAVERLY AVE. |
OCEANSIDE,
NY
11572
|
|
Correspondent Contact |
DMITRY DONSKOY |
Regulation Number | 878.4810
|
Classification Product Code |
|
Date Received | 03/09/2001 |
Decision Date | 10/04/2001 |
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
|