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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stretcher, Hand-Carried
510(k) Number K913520
Device Name EVACU SLED
Applicant
NEXUS HEALTH CARE PRODUCTS LTD.
160 JAMES STREET EAST
COBOURG, ONTARIO,  CA K9A 1H3
Applicant Contact JEFFREY SPARLING
Correspondent
NEXUS HEALTH CARE PRODUCTS LTD.
160 JAMES STREET EAST
COBOURG, ONTARIO,  CA K9A 1H3
Correspondent Contact JEFFREY SPARLING
Regulation Number880.6900
Classification Product Code
FPP  
Date Received08/07/1991
Decision Date 12/04/1991
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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