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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stretcher, Wheeled
510(k) Number K113598
Device Name POWER-LOAD COT FASTENER SYSTEM
Applicant
Stryker Medical
3800 E. Centre Ave.
Portage,  MI  49002
Applicant Contact RENATA SILA
Correspondent
Intertek Testing Services
2307 E. Aurora Rd.
Unit B7
Twinsburg,  OH  44087
Correspondent Contact BHAVESH V SHETH
Regulation Number880.6910
Classification Product Code
FPO  
Date Received12/05/2011
Decision Date 12/20/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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