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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Syringe, Piston
510(k) Number K894335
Device Name MODEL #535 PACU STRETCHER/BED & #530 ED/TRAUMA STR
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 Number880.5860
Classification Product Code
FMF  
Date Received07/14/1989
Decision Date 09/12/1989
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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