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510(k) K874758

DANTEC 13L40 ST. MARKS'S PUDENDAL ELECTRODE by Dantec Electronics, Inc. — Product Code FAP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 14, 1988
Date Received
November 18, 1987
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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