Device Classification Name |
Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
|
510(k) Number |
K163247 |
Device Name |
3.3 mm Laurimed Microdebrider; 4.0 mm Laurimed Microdebrider |
Applicant |
LAURIMED LLC |
500 ARGUELLO ST., SUITE 100 |
REDWOOD CITY,
CA
94063
|
|
Applicant Contact |
Brian R DuBois |
Correspondent |
LAURIMED LLC |
500 ARGUELLO ST., SUITE 100 |
REDWOOD CITY,
CA
94063
|
|
Correspondent Contact |
Brian R DuBois |
Regulation Number | 874.4250
|
Classification Product Code |
|
Date Received | 11/18/2016 |
Decision Date | 03/09/2017 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ear Nose & Throat
|
510k Review Panel |
Ear Nose & Throat
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|