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510(k) K971431

UMI X-RAY FILM CASSETTE by Umi Intl. — Product Code IXA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 20, 1997
Date Received
April 17, 1997
Clearance Type
Traditional
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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