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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Vessel Guard Or Cover
510(k) Number K101826
Device Name HYDROFIX VASO SHIELD, MODEL HVS-001-0610
Applicant
Mimedx Group, Inc.
811 Livingston Ct. SE
Suite B
Marietta,  GA  30067
Applicant Contact SALLY THORSEN
Correspondent
Mimedx Group, Inc.
811 Livingston Ct. SE
Suite B
Marietta,  GA  30067
Correspondent Contact SALLY THORSEN
Regulation Number870.3470
Classification Product Code
OMR  
Date Received07/01/2010
Decision Date 07/28/2010
Decision SE - With Limitations (SESU)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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