MODIFICATION TO STRYKER PAINPUMP2

Pump, Infusion

STRYKER INSTRUMENTS

The following data is part of a premarket notification filed by Stryker Instruments with the FDA for Modification To Stryker Painpump2.

Pre-market Notification Details

Device IDK030885
510k NumberK030885
Device Name:MODIFICATION TO STRYKER PAINPUMP2
ClassificationPump, Infusion
Applicant STRYKER INSTRUMENTS 4100 EAST MILHAM AVE. Kalamazoo,  MI  49001
ContactNicole Petty
CorrespondentNicole Petty
STRYKER INSTRUMENTS 4100 EAST MILHAM AVE. Kalamazoo,  MI  49001
Product CodeFRN  
CFR Regulation Number880.5725 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-03-21
Decision Date2003-04-18
Summary:summary

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