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FDA 510(k) Application Details - K181993
Device Classification Name
Sterilizer, Steam
More FDA Info for this Device
510(K) Number
K181993
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
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Classification Product Code
FLE
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More FDA Info for this Product Code
Date Received
07/26/2018
Decision Date
11/01/2019
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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