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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
510(k) Number K222640
Device Name Sweden & Martina Surgical Trays
Applicant
Sweden & Martina S.P.A.
Via Veneto, 10
Due Carrare,  IT 35020
Applicant Contact Alessia Pezzato
Correspondent
Sweden & Martina S.P.A.
Via Veneto, 10
Due Carrare,  IT 35020
Correspondent Contact Alessia Pezzato
Regulation Number880.6850
Classification Product Code
KCT  
Date Received09/01/2022
Decision Date 05/26/2023
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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