Device Classification Name |
Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
|
510(k) Number |
K161101 |
Device Name |
PolypVac Microdebrider (3.3mm and 4.0mm) |
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 | 04/19/2016 |
Decision Date | 06/22/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ear Nose & Throat
|
510k Review Panel |
Ear Nose & Throat
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|