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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 K223858
Device Name Lexa MINI (RIS-303, RIS-305)
Applicant
W&H Sterilization S.r.l.
Via Bolgara, 2
Brusaporto,  IT 24060
Applicant Contact Paola Zampino
Correspondent
W&H Sterilization S.r.l.
Via Bolgara, 2
Brusaporto,  IT 24060
Correspondent Contact Paola Zampino
Regulation Number880.6880
Classification Product Code
FLE  
Date Received12/23/2022
Decision Date 05/05/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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