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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name prosthesis, toe, hemi-, phalangeal
510(k) Number K113752
Device Name METATARSAL DECOMPRESSION IMPLANT SURGICAL INSTRUMENT SET
Original Applicant
SOLANA SURGICAL LLC
6363 poplar ave
suite 434
memphis,  TN  38119
Original Contact louise focht
Regulation Number888.3730
Classification Product Code
KWD  
Date Received12/21/2011
Decision Date 02/06/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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