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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 K940263
Device Name NPH-KLENZ
Applicant
Calgon Corp.
Sub. Merck & Co., Inc.
5035 Manchester Ave.
St. Louis,  MO  63110
Applicant Contact MICHAEL EBERS
Correspondent
Calgon Corp.
Sub. Merck & Co., Inc.
5035 Manchester Ave.
St. Louis,  MO  63110
Correspondent Contact MICHAEL EBERS
Regulation Number880.6150
Classification Product Code
FLG  
Date Received01/21/1994
Decision Date 05/18/1994
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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