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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 K953018
Device Name UNI-SITE
Applicant
Ttl Medical
10537 Lexington Dr.
Knoxville,  TN  37932
Applicant Contact H. CLAY WILSON
Correspondent
Ttl Medical
10537 Lexington Dr.
Knoxville,  TN  37932
Correspondent Contact H. CLAY WILSON
Classification Product Code
MGP  
Date Received06/29/1995
Decision Date 09/08/1995
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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