FDA 510(k), K000442, ACTI-GARD ANTIMICROBIAL FILM, MODELS D6635, D6640, D6648

510(k) Number    K000442
Device Name    ACTI-GARD ANTIMICROBIAL FILM, MODELS D6635, D6640, D6648
Device Classification Name    Drape, Surgical D6650,D6651, D66XX
Applicant    MEDICAL CONCEPTS DEVELOPMENT, INC.
Regulation Number    878.4370
Classification Product Code    KKX  
Date Received    02/10/2000
Decision Date    04/24/2001
Decision    Substantially Equivalent (SESE)
Regulation Medical Specialty    General & Plastic Surgery

Total pages: 1121
Fully redacted pages: 915
Content pages: 206