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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 K033666
Device Name HEMADERM
Applicant
MEDAFOR, INC.
2700 FREEWAY BLVD
SUITE 800
MINNEAPOLIS,  MN  55430
Applicant Contact JENNIFER A MAY
Correspondent
MEDAFOR, INC.
2700 FREEWAY BLVD
SUITE 800
MINNEAPOLIS,  MN  55430
Correspondent Contact JENNIFER A MAY
Classification Product Code
QSY  
Subsequent Product Codes
LYA   NHB  
Date Received11/21/2003
Decision Date 12/17/2003
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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