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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 K232485
Device Name AMSCO 600 Steam Sterilizer
Applicant
Steris
5960 Heisley Rd.
Mentor,  OH  44060
Applicant Contact Anthony Piotrkowski
Correspondent
Steris
5960 Heisley Rd.
Mentor,  OH  44060
Correspondent Contact Anthony Piotrkowski
Regulation Number880.6880
Classification Product Code
FLE  
Subsequent Product Code
PEC  
Date Received08/16/2023
Decision Date 09/13/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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