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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 K945431
Device Name MODEL 792 CONVERGE, MODEL 793 VISION 2000
Applicant
Hausted, Inc.
927 Lake Rd.
Medina,  OH  44256
Applicant Contact RAYMOND A FAILOR
Correspondent
Hausted, Inc.
927 Lake Rd.
Medina,  OH  44256
Correspondent Contact RAYMOND A FAILOR
Regulation Number880.6910
Classification Product Code
FPO  
Date Received08/15/1994
Decision Date 01/25/1995
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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