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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 K231489
Device Name Sturdy Autoclave Super Microm
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 Number880.6880
Classification Product Code
FLE  
Date Received05/23/2023
Decision Date 06/21/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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