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U.S. Department of Health and Human Services

510(k) Premarket Notification
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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.
# 168 Sec. 1, Zhongxing Rd., Wugu District
New Taipei City,  TW 24872
Applicant Contact Wolfgang Huang
Correspondent
Sturdy Industrial Co., Ltd.
# 168 Sec. 1, Zhongxing Rd., Wugu District
New Taipei City,  TW 24872
Correspondent Contact Wolfgang Huang
Regulation Number880.6880
Classification Product Code
FLE  
Date Received07/26/2018
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
Predetermined Change
Control Plan Authorized		 No
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