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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 K910789
Device Name KAVOKLAVE STEAM AUTOCLAVE
Applicant
Kavo America
1730 Pennsylvania Ave., NW
Washington,  DC  20006
Applicant Contact CHRIS THOMAS
Correspondent
Kavo America
1730 Pennsylvania Ave., NW
Washington,  DC  20006
Correspondent Contact CHRIS THOMAS
Regulation Number880.6880
Classification Product Code
FLE  
Date Received02/25/1991
Decision Date 08/26/1991
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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