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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 K940245
Device Name EVACU-SLED
Applicant
Evacu Technologies, Inc.
1008 Runningbrook Dr.
Mississauga
Ontario Canada L4y 2s9,  CA
Applicant Contact JOSEPH MANCINA
Correspondent
Evacu Technologies, Inc.
1008 Runningbrook Dr.
Mississauga
Ontario Canada L4y 2s9,  CA
Correspondent Contact JOSEPH MANCINA
Regulation Number880.6900
Classification Product Code
FPP  
Date Received01/19/1994
Decision Date 02/28/1994
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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