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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 K910080
Device Name KALTOSTAT WOUND PACKING
Applicant
Calgon Vestal Div.
P.O. Box 147
St. Louis,  MO  63166
Applicant Contact MICHAEL EBERS
Correspondent
Calgon Vestal Div.
P.O. Box 147
St. Louis,  MO  63166
Correspondent Contact MICHAEL EBERS
Classification Product Code
QSY  
Subsequent Product Code
LYA  
Date Received01/09/1991
Decision Date 03/20/1991
Decision Substantially Equivalent (SESE)
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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