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510(k) K041834

ADR PLUS SSXI IMAGING DEVICE FOR X-RAY SYSTEMS SUCH AS X-CALIBER, X-CALIBER CM, ANA-BEL AND ANA-BEL CM by Takara Belmont USA, Inc. — Product Code MUH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 3, 2004
Date Received
July 7, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Extraoral Source, Digital
Device Class
Class II
Regulation Number
872.1800
Review Panel
RA
Submission Type

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