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FDA 510(k) Application Details - K231489
Device Classification Name
Sterilizer, Steam
More FDA Info for this Device
510(K) Number
K231489
Device Name
Sterilizer, Steam
Applicant
Sturdy Industrial Co., Ltd
No. 168 Sec. 1, Zhongxing Road, Wugu District
New Taipei City 24872 TW
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Contact
Wolfgang Huang
Other 510(k) Applications for this Contact
Regulation Number
880.6880
More FDA Info for this Regulation Number
Classification Product Code
FLE
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More FDA Info for this Product Code
Date Received
05/23/2023
Decision Date
06/21/2023
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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