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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cleaner, Ultrasonic, Medical Instrument
510(k) Number K944494
Device Name ALSA-KLENZ
Applicant
Calgon Vestal Div.
P.O. Box 147
St. Louis,  MO  63166
Applicant Contact SUSIE AMBERGER
Correspondent
Calgon Vestal Div.
P.O. Box 147
St. Louis,  MO  63166
Correspondent Contact SUSIE AMBERGER
Regulation Number880.6150
Classification Product Code
FLG  
Date Received09/13/1994
Decision Date 10/19/1994
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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