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510(k) K042260

PHOT-X II, MODEL 303 by Takara Belmont USA, Inc. — Product Code EHD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 7, 2004
Date Received
August 23, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Unit, X-Ray, Extraoral With Timer
Device Class
Class II
Regulation Number
872.1800
Review Panel
RA
Submission Type

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