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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Finger, Constrained, Polymer
510(k) Number K140453
Device Name OSTEOTEC SILICONE FINGER IMPLANT
Applicant
Osteotec, Ltd.
9 Silver Business Park, Airfield Way
Christchurch, Dorset,  GB BH23 3TA
Applicant Contact ELIZABETH CLINTON-PARKER
Correspondent
Osteotec, Ltd.
9 Silver Business Park, Airfield Way
Christchurch, Dorset,  GB BH23 3TA
Correspondent Contact ELIZABETH CLINTON-PARKER
Regulation Number888.3230
Classification Product Code
KYJ  
Date Received02/24/2014
Decision Date 04/17/2015
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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