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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 K032192
Device Name PRE-VACUUM AUTOCLAVE WITH STEAM GENERATOR AND VERTICAL SLIDING DOOR, MODELS 4472 EP-1V AND 5596 EP-1V
Applicant
Tuttnauer U.S.A Co, Ltd.
1776 K St., NW
Suite 800
Washington,  DC  20006 -7910
Applicant Contact MARK M YACURA
Correspondent
Tuttnauer U.S.A Co, Ltd.
1776 K St., NW
Suite 800
Washington,  DC  20006 -7910
Correspondent Contact MARK M YACURA
Regulation Number880.6880
Classification Product Code
FLE  
Date Received07/17/2003
Decision Date 08/12/2004
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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