STRYKER PAINPUMP PCA

Pump, Infusion

STRYKER INSTRUMENTS

The following data is part of a premarket notification filed by Stryker Instruments with the FDA for Stryker Painpump Pca.

Pre-market Notification Details

Device IDK003543
510k NumberK003543
Device Name:STRYKER PAINPUMP PCA
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)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-11-17
Decision Date2001-06-05

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