Device Classification Name |
Sterilizer, Steam
|
510(k) Number |
K181993 |
Device Name |
STURDY Autoclave Super Microm (models SA-260MA and SA-260MA-R) |
Applicant |
Sturdy Industrial Co., Ltd |
No. 168 Sec. 1, Zhongxing Road, Wugu District |
New Taipei City,
TW
24872
|
|
Applicant Contact |
Wolfgang Huang |
Correspondent |
Sturdy Industrial Co., Ltd |
No. 168 Sec. 1, Zhongxing Road, Wugu District |
New Taipei City,
TW
24872
|
|
Correspondent Contact |
Wolfgang Huang |
Regulation Number | 880.6880
|
Classification Product Code |
|
Date Received | 07/26/2018 |
Decision Date | 11/01/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|