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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 K030334
Device Name T-SCIENTIFIC T-PAD
Applicant
T-Scientific, Inc.
1146 Gardencrest Ln.
Houston,  TX  77077
Applicant Contact DENNIS METCALF
Correspondent
T-Scientific, Inc.
1146 Gardencrest Ln.
Houston,  TX  77077
Correspondent Contact DENNIS METCALF
Classification Product Code
QSY  
Subsequent Product Code
LYA  
Date Received01/31/2003
Decision Date 04/21/2003
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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