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510(k) K021903

KODAK X-OMAT CASSETTE/LEADLESS FOR DENTAL USE by Eastman Kodak Company — Product Code IXA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 10, 2002
Date Received
June 10, 2002
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cassette, Radiographic Film
Device Class
Class II
Regulation Number
892.1850
Review Panel
RA
Submission Type

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