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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, Constrained, Polymer
510(k) Number K022887
Device Name INTERPHALANGEAL FLEXIBLE STABILIZING ROD SYSTEM
Applicant
Osteomed Corp.
3750 Realty Rd.
Addison,  TX  75001 -4311
Applicant Contact DAWN T HOLDEMAN
Correspondent
Osteomed Corp.
3750 Realty Rd.
Addison,  TX  75001 -4311
Correspondent Contact DAWN T HOLDEMAN
Regulation Number888.3720
Classification Product Code
KWH  
Date Received08/30/2002
Decision Date 11/26/2002
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
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