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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 K962282
Device Name TUTTNAUER PREVACUUM TABLE AUTOCLAVE
Applicant
TUTTNAUER USA CO. LTD.
33 COMAC LOOP, EQUI-PARK
RONKONKOMA,  NY  11779
Applicant Contact ROBERT R BASILE
Correspondent
TUTTNAUER USA CO. LTD.
33 COMAC LOOP, EQUI-PARK
RONKONKOMA,  NY  11779
Correspondent Contact ROBERT R BASILE
Regulation Number880.6880
Classification Product Code
FLE  
Date Received06/12/1996
Decision Date 11/12/1997
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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