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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 K063711
Device Name TUTTNAUER PREVACUUM STEAM HEATED AUTOCLAVE, MODELS 6990 SP-1A, 66120 SP-1A, 69150 SP-2A, 69120 L USA SP-2A, 69180 SP-2HA
Applicant
Tuttnauer Co. , Ltd.
1776 K St. NW
Suite 300
Washington,  DC  20006
Applicant Contact MARK YACURA
Correspondent
Tuttnauer Co. , Ltd.
1776 K St. NW
Suite 300
Washington,  DC  20006
Correspondent Contact MARK YACURA
Regulation Number880.6880
Classification Product Code
FLE  
Date Received12/14/2006
Decision Date 02/02/2007
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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