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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bandage, Liquid
510(k) Number K940407
Device Name KALTOGEL WOUND DRESSING
Applicant
Calgon Corp.
Sub. Merck & Co., Inc.
5035 Manchester Ave.
St. Louis,  MO  63110
Applicant Contact ANNE SCHMITT
Correspondent
Calgon Corp.
Sub. Merck & Co., Inc.
5035 Manchester Ave.
St. Louis,  MO  63110
Correspondent Contact ANNE SCHMITT
Regulation Number880.5090
Classification Product Code
KMF  
Date Received01/27/1994
Decision Date 04/07/1994
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
Regulation Medical Specialty General Hospital
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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