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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name prosthesis, nose, internal
510(k) Number K863399
Device Name BYRON DORSAL COLUMELLA IMPLANT
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 Number878.3680
Classification Product Code
FZE  
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
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