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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Methyl Methacrylate For Cranioplasty
510(k) Number K042414
Device Name VISIOPLAST ACRYLIC RESIN
Applicant
TECRES
ONE DEMOCRACY PLAZA
6701 DEMOCRACT BLVD. STE. 700
BETHESDA,  MD  20817
Applicant Contact CHRISTINE BRAUER
Correspondent
TECRES
ONE DEMOCRACY PLAZA
6701 DEMOCRACT BLVD. STE. 700
BETHESDA,  MD  20817
Correspondent Contact CHRISTINE BRAUER
Regulation Number882.5300
Classification Product Code
GXP  
Date Received09/07/2004
Decision Date 12/29/2004
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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