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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 K003543
Device Name STRYKER PAINPUMP PCA
Applicant
Stryker Instruments
4100 E. Milham Ave.
Kalamazoo,  MI  49001
Applicant Contact NICOLE PETTY
Correspondent
Stryker Instruments
4100 E. Milham Ave.
Kalamazoo,  MI  49001
Correspondent Contact NICOLE PETTY
Regulation Number880.5725
Classification Product Code
FRN  
Date Received11/17/2000
Decision Date 06/05/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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