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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 K923730
Device Name MODEL 561 C-ARM PROCEDURES STRETCHER
Applicant
Midmark Corp.
60 Vista Dr.
P.O. Box 286
Versailles,  OH  45380
Applicant Contact BRADLEY K SEIDEN
Correspondent
Midmark Corp.
60 Vista Dr.
P.O. Box 286
Versailles,  OH  45380
Correspondent Contact BRADLEY K SEIDEN
Regulation Number880.6910
Classification Product Code
FPO  
Date Received07/27/1992
Decision Date 02/09/1994
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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