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510(k) K992152

GENERAL PURPOSE TRANSDUCER STANDOFF, BIOPSY TRANSDUCER STANDOFF, BI-PLANE ENDOCAVITY TRANSDUCER STANDOFF by CIVCO Medical Instruments Co., Inc. — Product Code ITX

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: August 17, 1999
Date Received: June 25, 1999
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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