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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name prosthesis, chin, internal
510(k) Number K910457
Device Name ZARA EXTENDED CHIN IMPLANT
Applicant
BYRON MEDICAL
3280 E. HEMISPHERE LOOP
SUITE 100
TUCSON,  AZ  85706
Applicant Contact BYRON G ECONOMIDY
Correspondent
BYRON MEDICAL
3280 E. HEMISPHERE LOOP
SUITE 100
TUCSON,  AZ  85706
Correspondent Contact BYRON G ECONOMIDY
Regulation Number878.3550
Classification Product Code
FWP  
Date Received02/04/1991
Decision Date 02/19/1991
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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