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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name plate, bone
510(k) Number K855224
Device Name ACROMED NESTED BONE PLATE
Applicant
BUCKMAN CO., INC.
921 CALLE VERDE
MARTINEZ,  CA  94553
Applicant Contact DAVID W SHLERF
Correspondent
BUCKMAN CO., INC.
921 CALLE VERDE
MARTINEZ,  CA  94553
Correspondent Contact DAVID W SHLERF
Regulation Number872.4760
Classification Product Code
JEY  
Subsequent Product Code
HRS  
Date Received12/30/1985
Decision Date 02/04/1986
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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