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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 K950066
Device Name DENTAL IMPLANT ENDOSSEOUS
Applicant
"O" CO., INC.
600 PAISANO, N.E., SUITE A
ALBUQUERQUE,  NM  87123
Applicant Contact CONNIE L WHITE
Correspondent
"O" CO., INC.
600 PAISANO, N.E., SUITE A
ALBUQUERQUE,  NM  87123
Correspondent Contact CONNIE L WHITE
Regulation Number872.3640
Classification Product Code
DZE  
Date Received01/09/1995
Decision Date 09/15/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
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