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510(k) K042445

SITE-RITE NEEDLE GUIDE KITS AND PROBE COVER KIT by Bard Access Systems, Inc. — Product Code ITX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 19, 2004
Date Received
September 9, 2004
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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Other clearances for product code ITX

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