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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lavage, Jet
510(k) Number K873466
Device Name EXCEL PULSED IRRIGATION/SUCTION SYSTEM
Applicant
Stryker Corp.
420 Alcott St.
Kalamazoo,  MI  49001
Applicant Contact HARMON H WOODWORTH
Correspondent
Stryker Corp.
420 Alcott St.
Kalamazoo,  MI  49001
Correspondent Contact HARMON H WOODWORTH
Regulation Number880.5475
Classification Product Code
FQH  
Date Received08/28/1987
Decision Date 11/06/1987
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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