Device Classification Name |
Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
|
510(k) Number |
K081814 |
Device Name |
REPROCESSED ENT SHAVERS |
Applicant |
STERILMED, INC. |
11400 73RD AVE. N, STE. 100 |
MAPLE GROVE,
MN
55369
|
|
Applicant Contact |
JOSHUA CLARIN |
Correspondent |
STERILMED, INC. |
11400 73RD AVE. N, STE. 100 |
MAPLE GROVE,
MN
55369
|
|
Correspondent Contact |
JOSHUA CLARIN |
Regulation Number | 874.4250
|
Classification Product Code |
|
Date Received | 06/26/2008 |
Decision Date | 12/17/2008 |
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
|
|
|