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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name pump, infusion, pca
510(k) Number K030661
Device Name STRYKER PAINPUMP2
Original Applicant
STRYKER INSTRUMENTS
4100 east milham ave.
kalamazoo,  MI  49001
Original Contact nicole petty
Regulation Number880.5725
Classification Product Code
MEA  
Date Received03/03/2003
Decision Date 05/30/2003
Decision substantially equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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