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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dressing, Wound, Drug
510(k) Number K892868
Device Name KALTOSTAT WOUND PACKING
Applicant
Calgon Vestal Div.
5035 Manchester Ave.
St. Louis,  MO  63110
Applicant Contact RICHARD C JENTE
Correspondent
Calgon Vestal Div.
5035 Manchester Ave.
St. Louis,  MO  63110
Correspondent Contact RICHARD C JENTE
Classification Product Code
FRO  
Date Received04/19/1989
Decision Date 07/14/1989
Decision Substantially Equivalent (SESE)
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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