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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bur, Surgical, General & Plastic Surgery
510(k) Number K890090
Device Name DANEK IRRIGATING BURR (DIB) SET
Applicant
Danek Medical, Inc.
3092 Director'S Row
Memphis,  TN  38131
Applicant Contact FRANK M LEWIS
Correspondent
Danek Medical, Inc.
3092 Director'S Row
Memphis,  TN  38131
Correspondent Contact FRANK M LEWIS
Regulation Number878.4820
Classification Product Code
GFF  
Date Received01/10/1989
Decision Date 01/24/1989
Decision Substantially Equivalent (SESE)
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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