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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name System, Nuclear Magnetic Resonance Imaging
510(k) Number K993682
Device Name MRI EQUIPMENT COVER
Applicant
IMAGE-GUIDED NEUROLOGICS, INC.
2290 W. EAU GALLIE BLVD.
SUITE 210
MELBOURNE,  FL  32935
Applicant Contact DAVID M LEE
Correspondent
IMAGE-GUIDED NEUROLOGICS, INC.
2290 W. EAU GALLIE BLVD.
SUITE 210
MELBOURNE,  FL  32935
Correspondent Contact DAVID M LEE
Regulation Number892.1000
Classification Product Code
LNH  
Date Received11/01/1999
Decision Date 01/20/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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