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510(k) K001729

FOCUS by Instrumentarium Corp. — Product Code EHD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 13, 2000
Date Received
June 7, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

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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