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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 K002886
Device Name IMPLANTECH COMPOSITE FACIAL IMPLANTS (MALAR, CHIN, AND NASAL)
Applicant
Implantech Associates, Inc.
2064 Eastman Ave., Unit 101
Ventura,  CA  93003
Applicant Contact EDWARD LEICHT
Correspondent
Implantech Associates, Inc.
2064 Eastman Ave., Unit 101
Ventura,  CA  93003
Correspondent Contact EDWARD LEICHT
Regulation Number878.3550
Classification Product Code
LZK  
Date Received09/15/2000
Decision Date 11/24/2000
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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