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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, x-ray, extraoral source, digital
510(k) Number K060179
Device Name BIO-RAY SDX DIGITAL X-RAY SYSTEM
Applicant
SIGMA BIOMEDICS, INC.
65 E. PALATINE RD.
#201
PROSPECT HEIGHTS,  IL  60070
Applicant Contact KIM ANTOL
Correspondent
SIGMA BIOMEDICS, INC.
65 E. PALATINE RD.
#201
PROSPECT HEIGHTS,  IL  60070
Correspondent Contact KIM ANTOL
Regulation Number872.1800
Classification Product Code
MUH  
Date Received01/23/2006
Decision Date 02/08/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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