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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 K081876
Device Name OSTEOMED RESURFACING METATARSAL IMPLANT WITH HYDROXYLAPATITE COATING
Applicant
Osteomed LP
3885 Arapaho Rd.
Addison,  TX  75001
Applicant Contact ALMA RELJA
Correspondent
Osteomed LP
3885 Arapaho Rd.
Addison,  TX  75001
Correspondent Contact ALMA RELJA
Regulation Number888.3730
Classification Product Code
KWD  
Date Received07/02/2008
Decision Date 08/01/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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