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510(k) K131528

NON-PYROGENIC ULTRASOUND TRANSDUCER COVER by CIVCO Medical Instruments Co., Inc. — Product Code ITX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 11, 2013
Date Received
May 28, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

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

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