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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 K904011
Device Name MODEL #527 OPHTHALMIC STRETCHER
Applicant
Midmark Corp.
60 Vista Dr.
P.O. Box 286
Versailles,  OH  45380
Applicant Contact JOHN OLDIGES
Correspondent
Midmark Corp.
60 Vista Dr.
P.O. Box 286
Versailles,  OH  45380
Correspondent Contact JOHN OLDIGES
Regulation Number880.6910
Classification Product Code
FPO  
Date Received08/29/1990
Decision Date 10/03/1990
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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