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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 K072922
Device Name 3S HEMI TOE
Applicant
TRILLIANT SURGICAL LTD
1001 OAKWOOD BLVD
ROUND ROCK,  TX  78681
Applicant Contact JD WEBB
Correspondent
TRILLIANT SURGICAL LTD
1001 OAKWOOD BLVD
ROUND ROCK,  TX  78681
Correspondent Contact JD WEBB
Regulation Number888.3730
Classification Product Code
KWD  
Date Received10/15/2007
Decision Date 11/28/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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