Device Classification Name |
powered laser surgical instrument
|
510(k) Number |
K030959 |
Device Name |
BARE LASER FIBER MODELS DBLF-40, DBLF-60, DBLF-60-1, DCLF-600B, DSLF-60, DBLF-100 |
Applicant |
LASER PERIPHERALS LLC. |
1000 BOONE AVENUE NORTH |
SUITE 300 |
GOLDEN VALLEY,
MN
55427
|
|
Applicant Contact |
JEFFREY M STEIN |
Correspondent |
LASER PERIPHERALS LLC. |
1000 BOONE AVENUE NORTH |
SUITE 300 |
GOLDEN VALLEY,
MN
55427
|
|
Correspondent Contact |
JEFFREY M STEIN |
Regulation Number | 878.4810
|
Classification Product Code |
|
Date Received | 03/27/2003 |
Decision Date | 04/25/2003 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Statement |
Statement
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|