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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Post, Root Canal
510(k) Number K974649
Device Name BIO-POST DENTAL POST SYSTEM
Applicant
Advanced Aeromedical, Inc.
55 Northern Blvd., Suite 410
Great Neck,,  NY  11021
Applicant Contact CAROLANN KOTULA
Correspondent
Advanced Aeromedical, Inc.
55 Northern Blvd., Suite 410
Great Neck,,  NY  11021
Correspondent Contact CAROLANN KOTULA
Regulation Number872.3810
Classification Product Code
ELR  
Date Received12/12/1997
Decision Date 05/01/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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