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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dressing, Wound And Burn, Occlusive
510(k) Number K943424
Device Name CUSH ISLAND DRESSING
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
Classification Product Code
MGP  
Date Received07/15/1994
Decision Date 10/03/1994
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
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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