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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tray, Surgical
510(k) Number K940239
Device Name EYE TRAY
Applicant
Cush Medical Products
P.O. Box 247
881 Mountain View Dr.
Piney Flats,  TN  37686
Applicant Contact STEVE B JOHNSTON
Correspondent
Cush Medical Products
P.O. Box 247
881 Mountain View Dr.
Piney Flats,  TN  37686
Correspondent Contact STEVE B JOHNSTON
Regulation Number878.4800
Classification Product Code
LRP  
Date Received01/19/1994
Decision Date 06/28/1994
Decision Substantially Equivalent - Kit With Drugs (SEKD)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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