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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name monitor, pressure, intracompartmental
510(k) Number K844214
Device Name COMPARTMENT SYNDROME PRESSURE MONITOR SYS
Applicant
STRYKER CORP.
420 ALCOTT ST.
KALAMAZOO,  MI  49001
Applicant Contact MARY C MASTENBROOK
Correspondent
STRYKER CORP.
420 ALCOTT ST.
KALAMAZOO,  MI  49001
Correspondent Contact MARY C MASTENBROOK
Classification Product Code
LXC  
Date Received10/31/1984
Decision Date 04/04/1985
Decision Substantially Equivalent (SESE)
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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