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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 K892364
FOIA Releasable 510(k) K892364
Device Name KALTOSTAT(TM) WOUND DRESSING
Applicant
Calgon Vestal Div.
P.O. Box 147
St. Louis,  MO  63166
Applicant Contact RICHARD C JENTE
Correspondent
Calgon Vestal Div.
P.O. Box 147
St. Louis,  MO  63166
Correspondent Contact RICHARD C JENTE
Classification Product Code
FRO  
Date Received04/06/1989
Decision Date 06/23/1989
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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