Device Classification Name |
single-use reprocessed ultrasonic surgical instruments
|
510(k) Number |
K143562 |
Device Name |
Reprocessed Cordless Ultrasonic Dissection Device |
Applicant |
STERILMED, INC. |
11400 73RD AVE. N |
Maple Grove,
MN
55369
|
|
Applicant Contact |
Nicole Boser |
Correspondent |
LIBRA MEDICAL |
8401 73RD AVE NORTH, SUITE 63 |
BROOKLYN PARK,
MN
55448
|
|
Correspondent Contact |
JULIE BODMER |
Classification Product Code |
|
Date Received | 12/16/2014 |
Decision Date | 05/20/2015 |
Decision |
Substantially Equivalent
(SESE) |
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|