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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Hemostatic Wound Dressing Without Thrombin Or Other Biologics
510(k) Number K904488
Device Name KALTOSTAT WOUND DRESSING
Applicant
Calgon Vestal Div.
P.O. Box 147
St. Louis,  MO  63166
Applicant Contact DONNA GODWARD
Correspondent
Calgon Vestal Div.
P.O. Box 147
St. Louis,  MO  63166
Correspondent Contact DONNA GODWARD
Classification Product Code
QSY  
Subsequent Product Code
LYA  
Date Received10/02/1990
Decision Date 12/12/1990
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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