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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, X-Ray, Extraoral With Timer
510(k) Number K020070
Device Name JB-70 INTRAORAL X-RAY SYSTEM, MODELS 30-A0001/A0002
Applicant
PROGENY, INC.
1407 BARCLAY BLVD.
BUFFALO GROVE,  IL  60089
Applicant Contact ALAN KREMA
Correspondent
PROGENY, INC.
1407 BARCLAY BLVD.
BUFFALO GROVE,  IL  60089
Correspondent Contact ALAN KREMA
Regulation Number872.1800
Classification Product Code
EHD  
Date Received01/09/2002
Decision Date 02/01/2002
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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