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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 K021678
Device Name HEMADERM COTAINING HEMADEX CLOTTING BEADS
Applicant
Medafor, Inc.
5201 E. River Rd., # 312
Minneapolis,  MN  55421
Applicant Contact PHILIP B JARVI
Correspondent
Medafor, Inc.
5201 E. River Rd., # 312
Minneapolis,  MN  55421
Correspondent Contact PHILIP B JARVI
Classification Product Code
QSY  
Date Received05/21/2002
Decision Date 07/12/2002
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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