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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name General Surgery Tray
510(k) Number K935686
Device Name DRESSING CHANGE 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 Number878.4370
Classification Product Code
LRO  
Subsequent Product Code
FRG  
Date Received11/29/1993
Decision Date 02/25/1994
Decision Substantially Equivalent - Kit (SESK)
Regulation Medical Specialty General & Plastic Surgery
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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