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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name abutment, implant, dental, endosseous
510(k) Number K021460
Device Name OCO DENTAL IMPLANT
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 Number872.3630
Classification Product Code
NHA  
Subsequent Product Code
DZE  
Date Received05/07/2002
Decision Date 05/22/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
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