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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 K220736
Device Name Consolidated HC Steam Sterilizer
Applicant
Consolidated Machine Corp.
3 Enterprise Rd, Suite C
Billerica,  MA  01821
Applicant Contact Arthur Trapotsis
Correspondent
Consolidated Machine Corp.
3 Enterprise Rd, Suite C
Billerica,  MA  01821
Correspondent Contact Arthur Trapotsis
Regulation Number880.6880
Classification Product Code
FLE  
Date Received03/14/2022
Decision Date 08/01/2022
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
Predetermined Change
Control Plan Authorized		 No
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