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510(k) K925869

SHEATHES, STERILE SHEATHES by Mayer Laboratories — Product Code ITX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 6, 1994
Date Received
November 19, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Transducer, Ultrasonic, Diagnostic
Device Class
Class II
Regulation Number
892.1570
Review Panel
RA
Submission Type

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