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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 K021504
Device Name TUTTNAUER EHS SERIES TABLE-TOP AUTOCLAVE, MODEL 2540
Applicant
Tuttnauer U.S.A Co, Ltd.
1776 K St., NW
Suite 800
Washington,  DC  20006
Applicant Contact TODD H HALPERN
Correspondent
Tuttnauer U.S.A Co, Ltd.
1776 K St., NW
Suite 800
Washington,  DC  20006
Correspondent Contact TODD H HALPERN
Regulation Number880.6880
Classification Product Code
FLE  
Date Received05/09/2002
Decision Date 07/25/2002
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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