Device Classification Name |
Powered Laser Surgical Instrument
|
510(k) Number |
K122159 |
Device Name |
DORNIER MEDILAS H30 SOLVO |
Applicant |
DORNIER MEDTECH AMERICA, INC. |
1155 ROBERTS BLVD. |
KENNESAW,
GA
30144
|
|
Applicant Contact |
JOHN HOFFER |
Correspondent |
DORNIER MEDTECH AMERICA, INC. |
1155 ROBERTS BLVD. |
KENNESAW,
GA
30144
|
|
Correspondent Contact |
JOHN HOFFER |
Regulation Number | 878.4810
|
Classification Product Code |
|
Date Received | 07/20/2012 |
Decision Date | 02/01/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|