SYNTHES (USA) COMPARTMENTAL PRESSURE MONITORING SYSTEM

Monitor, Pressure, Intracompartmental

SYNTHES (USA)

The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes (usa) Compartmental Pressure Monitoring System.

Pre-market Notification Details

Device IDK031555
510k NumberK031555
Device Name:SYNTHES (USA) COMPARTMENTAL PRESSURE MONITORING SYSTEM
ClassificationMonitor, Pressure, Intracompartmental
Applicant SYNTHES (USA) 1690 RUSSELL RD. P.O. BOX 1766 Paoli,  PA  19301
ContactLisa M Boyle
CorrespondentLisa M Boyle
SYNTHES (USA) 1690 RUSSELL RD. P.O. BOX 1766 Paoli,  PA  19301
Product CodeLXC  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-05-19
Decision Date2003-07-08
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
H6795304130 K031555 000
H6795304120 K031555 000
H6795304110 K031555 000

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