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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Treadmill, Mechanical
510(k) Number K920526
Device Name STRYKER DYNAMIC MATTRESS SYSTEM (DMS) MODEL #2500
Applicant
STRYKER MEDICAL
6300 S. SPRINKLE RD.
KALAMAZOO,  MI  49001 -9799
Applicant Contact JAMES A AHLE
Correspondent
STRYKER MEDICAL
6300 S. SPRINKLE RD.
KALAMAZOO,  MI  49001 -9799
Correspondent Contact JAMES A AHLE
Regulation Number890.5370
Classification Product Code
IOG  
Date Received02/04/1992
Decision Date 09/21/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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