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510(k) K972968

ROTOGRAPH PLUS by Chicago X-Ray Systems, Inc. — Product Code EHD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 8, 1997
Date Received
August 11, 1997
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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