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FDA 510(k) Application Details - K172825
Device Classification Name
Sterilizer, Steam
More FDA Info for this Device
510(K) Number
K172825
Device Name
Sterilizer, Steam
Applicant
W&H Sterilization s.r.l.
Via Bolgara, 2
Brusaporto IT
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Contact
Marco Parolini
Other 510(k) Applications for this Contact
Regulation Number
880.6880
More FDA Info for this Regulation Number
Classification Product Code
FLE
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/18/2017
Decision Date
05/30/2018
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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