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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Negative Pressure Wound Therapy Powered Suction Pump
510(k) Number K161570
Device Name Theia NPWT Foam Wound Dressing Kit-Small, Theia NPWT Foam Wound Dressing Kit-Medium, Theia NPWT Foam Wound Dressing Kit-Large
Applicant
Lc Medical Concepts, Inc.
P.O. Box 502
Penfield,  NY  14526
Applicant Contact Dana M. Ledgerwood
Correspondent
Lc Medical Concepts, Inc.
P.O. Box 502
Penfield,  NY  14526
Correspondent Contact Dana M. Ledgerwood
Regulation Number878.4780
Classification Product Code
OMP  
Date Received06/07/2016
Decision Date 08/29/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
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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