Device Classification Name |
drill, surgical, ent (electric or pneumatic) including handpiece
|
510(k) Number |
K133133 |
Device Name |
LAURIMED POLYPVAC MICRODEBRIDER |
Applicant |
LAURIMED LLC |
8 CROW CANYON COURT, STE 205 |
SAN RAMON,
CA
94583
|
|
Applicant Contact |
NANCY LINCE, RAC |
Correspondent |
LAURIMED LLC |
8 CROW CANYON COURT, STE 205 |
SAN RAMON,
CA
94583
|
|
Correspondent Contact |
NANCY LINCE, RAC |
Regulation Number | 874.4250
|
Classification Product Code |
|
Date Received | 09/30/2013 |
Decision Date | 12/23/2013 |
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
|
Recalls |
CDRH Recalls
|
|
|