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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 K021417
Device Name AART CHIN IMPLANT
Applicant
AESTHETIC AND RECONSTRUCTIVE TECHNOLOGIES, INC.
3545 AIRWAY DR.
SUITE 108
RENO,  NV  89511
Applicant Contact CATHERINE RIPLE
Correspondent
AESTHETIC AND RECONSTRUCTIVE TECHNOLOGIES, INC.
3545 AIRWAY DR.
SUITE 108
RENO,  NV  89511
Correspondent Contact CATHERINE RIPLE
Regulation Number878.3550
Classification Product Code
FWP  
Date Received05/03/2002
Decision Date 07/02/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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