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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 K933149
Device Name INSTRUMENT DETERGENT CONCENTRATE
Applicant
Nobelpharma USA, Inc.
5101 S. Keeler Ave.
Chicago,  IL  60632
Applicant Contact ALAN I BECKER
Correspondent
Nobelpharma USA, Inc.
5101 S. Keeler Ave.
Chicago,  IL  60632
Correspondent Contact ALAN I BECKER
Regulation Number880.6150
Classification Product Code
FLG  
Date Received06/29/1993
Decision Date 02/16/1994
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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