Device Classification Name |
powered laser surgical instrument
|
510(k) Number |
K120437 |
Device Name |
TWISTER SIDE-FIRE FIBER OPTIC DELIVERY SYSTEM |
Applicant |
BIOLITEC SIA (LATVIA) |
1349 MAIN ROAD |
GRANVILLE,
MA
01034
|
|
Applicant Contact |
HARRY HAYES |
Correspondent |
BIOLITEC SIA (LATVIA) |
1349 MAIN ROAD |
GRANVILLE,
MA
01034
|
|
Correspondent Contact |
HARRY HAYES |
Regulation Number | 878.4810
|
Classification Product Code |
|
Date Received | 02/13/2012 |
Decision Date | 04/26/2012 |
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
|