FDA 510(k) Application Details - K944950

Device Classification Name Cleaner, Ultrasonic, Medical Instrument

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510(K) Number K944950
Device Name Cleaner, Ultrasonic, Medical Instrument
Applicant CALGON CORP.
SUB. MERCK & CO., INC.
5035 MANCHESTER AVE.
ST. LOUIS, MO US
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Contact MICHAEL EBERS
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Regulation Number 880.6150

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Classification Product Code FLG
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Date Received 10/07/1994
Decision Date 12/20/1994
Decision SE - Substantially Equivalent
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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