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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cannula, Surgical, General & Plastic Surgery
510(k) Number K862936
Device Name NEWMAN CANNULAE SYSTEM (NCS)
Applicant
Byron Medical
3280 E. Hemisphere Loop
Suite 100
Tucson,  AZ  85706
Applicant Contact BYRON ECONOMIDY
Correspondent
Byron Medical
3280 E. Hemisphere Loop
Suite 100
Tucson,  AZ  85706
Correspondent Contact BYRON ECONOMIDY
Regulation Number878.4800
Classification Product Code
GEA  
Date Received08/04/1986
Decision Date 08/14/1986
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
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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