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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Implant, Malar
510(k) Number K863400
Device Name BYRON EXTENDED MALAR AND BYRON CONTOURED MALAR
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 Number878.3550
Classification Product Code
LZK  
Date Received09/03/1986
Decision Date 09/17/1986
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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