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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, absorbable, orthopaedics, reinforcement of tendon
510(k) Number K121216
Device Name STR GRAFT
Original Applicant
815 iris lane
vero beach,  FL  32963
Original Contact robert a poggie
Regulation Number878.3300
Classification Product Code
Subsequent Product Code
Date Received04/23/2012
Decision Date 11/21/2012
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