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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dressing, Wound, Drug
510(k) Number K093544
Device Name TROPAZONE CR
Applicant
Midlothian Laboratories
760 Industrial Park Blvd.
Unit C
Montgomery,  AL  36117
Applicant Contact BRYCE HARVEY
Correspondent
Midlothian Laboratories
760 Industrial Park Blvd.
Unit C
Montgomery,  AL  36117
Correspondent Contact BRYCE HARVEY
Classification Product Code
FRO  
Date Received11/17/2009
Decision Date 02/16/2010
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
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