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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 K973926
Device Name O BUTMENT HS IMPLANT
Applicant
"O" Co., Inc.
600 Paisano, NE, Suite A
Albuquerque,  NM  87123
Applicant Contact DAVID D DALISE
Correspondent
"O" Co., Inc.
600 Paisano, NE, Suite A
Albuquerque,  NM  87123
Correspondent Contact DAVID D DALISE
Regulation Number872.3640
Classification Product Code
DZE  
Date Received10/15/1997
Decision Date 01/05/1998
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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