510(k) K951805

PIPER, MODEL NUMBER UDS-PIPERB by Laborie Medical Technologies, Ltd. — Product Code FEN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 6, 1995
Date Received
April 18, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Cystometric, Hydraulic
Device Class
Class II
Regulation Number
876.1620
Review Panel
GU
Submission Type