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510(k) K913301

MCS 50MO X-RAY TUBE INSERT/MXS 50MO TUBE HOU ASSEM by Comet North America, Inc. — Product Code ITY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 28, 1991
Date Received
July 25, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Assembly, Tube Housing, X-Ray, Diagnostic
Device Class
Class I
Regulation Number
892.1760
Review Panel
RA
Submission Type

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