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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 K100613
Device Name BIOMED WOUND CLEANSER
Applicant
Biomed Laboratories, Inc.
2713 Industrial Ln.
Garland,  TX  75041
Applicant Contact DONALD G WHITE
Correspondent
Biomed Laboratories, Inc.
2713 Industrial Ln.
Garland,  TX  75041
Correspondent Contact DONALD G WHITE
Classification Product Code
FRO  
Date Received03/04/2010
Decision Date 01/05/2011
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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