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510(k) K974775

SINGLE CHANNEL UROLOGICAL PRESSURE GAUGE, DUAL CHANNEL UROLOGICAL PRESSURE GAUGE by Airtronic Services, Inc. — Product Code FAP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 19, 1998
Date Received
December 22, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cystometric Gas (Carbon-Dioxide) On Hydraulic Device
Device Class
Class II
Regulation Number
876.1620
Review Panel
GU
Submission Type

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