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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
510(k) Number K014091
Device Name STRYKER PAINPUMP
Applicant
STRYKER CORP.
4100 E. MILHAM AVE.
KALAMAZOO,  MI  49001
Applicant Contact NICOLE PETTY
Correspondent
STRYKER CORP.
4100 E. MILHAM AVE.
KALAMAZOO,  MI  49001
Correspondent Contact NICOLE PETTY
Regulation Number880.5725
Classification Product Code
FRN  
Date Received12/12/2001
Decision Date 12/31/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
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