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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 K033392
Device Name IMMEDIATE STABILIZING IMPLANT (ISI)
Applicant
"O" CO., INC.
600 PAISANO, N.E., SUITE A
ALBUQUERQUE,  NM  87123
Applicant Contact DAVID D DALISE
Correspondent
"O" CO., INC.
600 PAISANO, N.E., SUITE A
ALBUQUERQUE,  NM  87123
Correspondent Contact DAVID D DALISE
Regulation Number872.3640
Classification Product Code
DZE  
Date Received10/23/2003
Decision Date 12/10/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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