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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Protector, Skin Pressure
510(k) Number K150243
Device Name Invictus Medical GelShield
Applicant
Invictus Medical, Inc.
12500 Network Blvd., Suite 308
San Antonio,  TX  78249
Applicant Contact Chris Gilmer
Correspondent
Navigant Consulting
9001 Wesleyan Rd.
Suite 200
Indianpolis,  IN  46268
Correspondent Contact Scott Thiel
Regulation Number880.6450
Classification Product Code
FMP  
Date Received02/02/2015
Decision Date 05/01/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Clinical Trials NCT02224859
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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