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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
SOFT TISSUE REGENERATION, INC.
815 iris lane
vero beach,  FL  32963
Original Contact robert a poggie
Regulation Number878.3300
Classification Product Code
OWW  
Subsequent Product Code
OWT  
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
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