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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, alterable
510(k) Number K100205
Device Name FRONTIER DEVICES NEURO SYSTEM
Applicant
FOLSOM METAL PRODUCTS, INC.
153 CAHABA VALLEY PKWY.
PELHAM,  AL  35124
Applicant Contact DON PETERSON
Correspondent
FOLSOM METAL PRODUCTS, INC.
153 CAHABA VALLEY PKWY.
PELHAM,  AL  35124
Correspondent Contact DON PETERSON
Regulation Number882.5320
Classification Product Code
GWO  
Subsequent Product Codes
GXR   HBW  
Date Received01/25/2010
Decision Date 12/13/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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