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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Disinfectant, Medical Devices
510(k) Number K974304
Device Name GERMICIDAL CLOTH
Applicant
Convatec, A Division of E.R. Squibb & Sons
5035 Manchester Ave.
St. Louis,  MO  63110
Applicant Contact MIKE EBERS
Correspondent
Convatec, A Division of E.R. Squibb & Sons
5035 Manchester Ave.
St. Louis,  MO  63110
Correspondent Contact MIKE EBERS
Regulation Number880.6890
Classification Product Code
LRJ  
Date Received11/17/1997
Decision Date 01/13/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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