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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 K842754
Device Name CUSTOM ULTRASONICS-SYS 80, 81-24, 83-2
Applicant
Custom Ultrasonics
P.O. Box 850
Buckingham,  PA  18912
Applicant Contact FRANK J WEBER
Correspondent
Custom Ultrasonics
P.O. Box 850
Buckingham,  PA  18912
Correspondent Contact FRANK J WEBER
Regulation Number880.6150
Classification Product Code
FLG  
Date Received07/16/1984
Decision Date 11/28/1984
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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