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510(k) K970514

DISPOSABLE TRANSRECTAL/TRANSVAGINAL/ENDOCAVITY ULTRASOUND NEEDLE INSTRUMENT GUIDE by CIVCO Medical Instruments Co., Inc. — Product Code ITX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 20, 1997
Date Received
February 11, 1997
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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