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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 K884660
Device Name BIOSONIC ULTRASONIC CLEANING SYSTEM
Applicant
Whaledent Intl. Div. Ipco
Consultant
36 Maplewood Rd.
Hartsdale,  NY  10530
Applicant Contact L WOLFSON
Correspondent
Whaledent Intl. Div. Ipco
Consultant
36 Maplewood Rd.
Hartsdale,  NY  10530
Correspondent Contact L WOLFSON
Regulation Number880.6150
Classification Product Code
FLG  
Date Received11/07/1988
Decision Date 03/16/1989
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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