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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plate, Cranioplasty, Preformed, Non-Alterable
510(k) Number K022277
Device Name OSTEOMED CRANIAL FLAP FIXATION 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 Number882.5330
Classification Product Code
GXN  
Date Received07/15/2002
Decision Date 04/01/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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