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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name mesh, surgical
510(k) Number K160181
Device Name COLORADO THERAPEUTICS XENOGRAFT IMPLANT
Applicant
Colorado Therapeutics LLC
2150 WEST 6TH AVENUE
SUITE L
BROOMFIELD,  CO  80020
Applicant Contact WILLIAM JACKSON
Correspondent
Colorado Therapeutics LLC
2150 WEST 6TH AVENUE
SUITE L
BROOMFIELD,  CO  80020
Correspondent Contact WILLIAM JACKSON
Regulation Number878.3300
Classification Product Code
FTM  
Subsequent Product Code
OXK  
Date Received01/27/2016
Decision Date 10/20/2016
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
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