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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 K062570
Device Name PATIENT CONTOURED MESH (PCM)
Applicant
KLS-MARTIN L.P.
11239 ST. JOHNS INDUSTRIAL
PARKWAY SOUTH
JACKSONVILLE,  FL  32246
Applicant Contact JENNIFER DAMATO
Correspondent
KLS-MARTIN L.P.
11239 ST. JOHNS INDUSTRIAL
PARKWAY SOUTH
JACKSONVILLE,  FL  32246
Correspondent Contact JENNIFER DAMATO
Regulation Number882.5330
Classification Product Code
GXN  
Date Received08/31/2006
Decision Date 10/31/2006
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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