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FDA 510(k) Application Details - K031448
Device Classification Name
Unit, X-Ray, Extraoral With Timer
More FDA Info for this Device
510(K) Number
K031448
Device Name
Unit, X-Ray, Extraoral With Timer
Applicant
VISIODENT SA
110 E GRANADA BLVD.
STE 207 & 208; PO BOX 36
ORMOND BEACH, FL 32175-0036 US
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Contact
CLAUDE D BERTHOIN
Other 510(k) Applications for this Contact
Regulation Number
872.1800
More FDA Info for this Regulation Number
Classification Product Code
EHD
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/07/2003
Decision Date
07/31/2003
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
DE - Dental
Review Advisory Committee
RA - Radiology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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