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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Implant, Endosseous, Root-Form
510(k) Number K962753
Device Name KWAN HEXAGONAL ABUTMENT IMPLANT SYSTEM (HAIS)
Applicant
Biomedical Implant Technology, Inc.
10304 Islander Dr.
Boca Raton,  FL  33498
Applicant Contact RONALD MCCARLEY
Correspondent
Biomedical Implant Technology, Inc.
10304 Islander Dr.
Boca Raton,  FL  33498
Correspondent Contact RONALD MCCARLEY
Regulation Number872.3640
Classification Product Code
DZE  
Date Received07/15/1996
Decision Date 05/19/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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