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510(k) K031555

SYNTHES (USA) COMPARTMENTAL PRESSURE MONITORING SYSTEM by Synthes (Usa) — Product Code LXC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 8, 2003
Date Received
May 19, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Pressure, Intracompartmental
Device Class
Class U
Regulation Number
Review Panel
OR
Submission Type

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