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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 K250168
Device Name Life Ultra 25L Tabletop Mono Chamber Steam Sterilizer
Applicant
Lucas Lifecare
2302 Beloit Ave.
Janesville,  WI  53546
Applicant Contact Joseph Paul Vincent
Correspondent
Lourdes Lifecare
# 1536, 17th B Main,
Hbr Layout
Bengaluru,  IN 560 043
Correspondent Contact Anand Vangala
Regulation Number880.6880
Classification Product Code
FLE  
Date Received01/21/2025
Decision Date 12/30/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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