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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 K213545
Device Name Steelco VS Series Steam Sterilizers, models 262839, 262851, 262869
Applicant
Steelco S.P.A.
Via Balegante, 27
Riese Pio X,  IT 31039
Applicant Contact Veronica Basso
Correspondent
H & W Technology, LLC
440 W. Sedgwick St. B109
Philadelphia,  PA  19119
Correspondent Contact Jonathan A Wilder
Regulation Number880.6880
Classification Product Code
FLE  
Date Received11/08/2021
Decision Date 02/02/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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