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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 K920478
Device Name TUTTNAUER LSI (AUTOMATIC)
Applicant
Tuttnauer Co. , Ltd.
One Comac Loop
Equi-Park
Ronkonkoma,  NY  11779
Applicant Contact ROBERT R BASILE
Correspondent
Tuttnauer Co. , Ltd.
One Comac Loop
Equi-Park
Ronkonkoma,  NY  11779
Correspondent Contact ROBERT R BASILE
Regulation Number880.6880
Classification Product Code
FLE  
Date Received01/29/1992
Decision Date 07/08/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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