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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bandage, Liquid
510(k) Number K013225
Device Name INSTACLOT FOR OTC USE, TRAUMASSTAT FOR PRESCRIPTION USE
Applicant
MEDAFOR, INC.
5201 EAST RIVER ROAD, # 312
MINNEAPOLIS,  MN  55421 -1035
Applicant Contact PHILIP B JARVI
Correspondent
MEDAFOR, INC.
5201 EAST RIVER ROAD, # 312
MINNEAPOLIS,  MN  55421 -1035
Correspondent Contact PHILIP B JARVI
Regulation Number880.5090
Classification Product Code
KMF  
Date Received09/27/2001
Decision Date 12/26/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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