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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 And Burn, Occlusive
510(k) Number K954602
Device Name FLEXZAN WOUND DRESSING
Applicant
Dow Hickam Pharmaceuticals, Inc.
10410 Corporate Dr.
Sugar Land,  TX  77478
Applicant Contact BARBARA THOMAS SMITH
Correspondent
Dow Hickam Pharmaceuticals, Inc.
10410 Corporate Dr.
Sugar Land,  TX  77478
Correspondent Contact BARBARA THOMAS SMITH
Classification Product Code
MGP  
Date Received09/27/1995
Decision Date 11/02/1995
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
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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