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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 K944904
Device Name PARRALLEL PIN
Applicant
"O" CO., INC.
600 PAISANO, N.E., SUITE A
albuquerque,  NM  87123
Applicant Contact connie white
Correspondent
"O" CO., INC.
600 PAISANO, N.E., SUITE A
albuquerque,  NM  87123
Correspondent Contact connie white
Regulation Number872.3640
Classification Product Code
DZE  
Date Received10/05/1994
Decision Date 02/16/1995
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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