Device Classification Name |
single-use reprocessed ultrasonic surgical instruments
|
510(k) Number |
K190610 |
Device Name |
Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue Technology |
Applicant |
Sterilmed, Inc. |
5010 Cheshire Parkway N, Suite 2 |
Plymouth,
MN
55446
|
|
Applicant Contact |
Jan Flegeau |
Correspondent |
Sterilmed, Inc. |
5010 Cheshire Parkway N, Suite 2 |
Plymouth,
MN
55446
|
|
Correspondent Contact |
Jan Flegeau |
Classification Product Code |
|
Date Received | 03/11/2019 |
Decision Date | 08/15/2019 |
Decision |
Substantially Equivalent
(SESE) |
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|