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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Tape, Measuring, Rulers And Calipers
510(k) Number K883485
Device Name STRYKER PRESSURE MONITOR 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 Number878.4800
Classification Product Code
FTY  
Date Received08/16/1988
Decision Date 09/13/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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