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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 K864269
Device Name MODEL 35-B ALL LEVEL COT
Applicant
FERNO-WASHINGTON, INC.
70 WEIL WAY
WILMINGTON,  OH  45177
Applicant Contact ERIC BESANKO
Correspondent
FERNO-WASHINGTON, INC.
70 WEIL WAY
WILMINGTON,  OH  45177
Correspondent Contact ERIC BESANKO
Regulation Number880.6910
Classification Product Code
FPO  
Date Received10/29/1986
Decision Date 11/13/1986
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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