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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 K232658
Device Name T-Top 10 & T-Top T-Top 11
Applicant
Tuttnauer U.S.A Co, Ltd.
25 Power Dr. Hauppauge
New York,  NY  11788
Applicant Contact Jonathan Lane
Correspondent
Tuttnauer U.S.A Co, Ltd.
25 Power Dr. Hauppauge
New York,  NY  11788
Correspondent Contact Jonathan Lane
Regulation Number880.6880
Classification Product Code
FLE  
Date Received08/31/2023
Decision Date 11/27/2023
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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