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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 K993856
Device Name TUTTNAUER ELECTRONIC AUTOCLAVE, MODELS E, EA, EK, EKA, EP
Applicant
Tuttnauer U.S.A Co, Ltd.
1776 K St., NW
Suite 800
Washington,  DC  20006
Applicant Contact MARK M YACURA
Correspondent
Tuttnauer U.S.A Co, Ltd.
1776 K St., NW
Suite 800
Washington,  DC  20006
Correspondent Contact MARK M YACURA
Regulation Number880.6880
Classification Product Code
FLE  
Date Received11/15/1999
Decision Date 02/09/2001
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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