Device Classification Name |
Powered Laser Surgical Instrument
|
510(k) Number |
K030235 |
Device Name |
F1 DIODE LASER SYSTEM |
Applicant |
OPUS MEDICAL, INC. |
1684 EAST GUDE DR. |
SUITE 202 |
ROCKVILLE,
MD
20850
|
|
Applicant Contact |
RENE VAN DE ZANDE |
Correspondent |
OPUS MEDICAL, INC. |
1684 EAST GUDE DR. |
SUITE 202 |
ROCKVILLE,
MD
20850
|
|
Correspondent Contact |
RENE VAN DE ZANDE |
Regulation Number | 878.4810
|
Classification Product Code |
|
Date Received | 01/23/2003 |
Decision Date | 04/23/2003 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|