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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plate, Fixation, Bone
510(k) Number K922167
Device Name ALPHATEC COMPRESSION AND RECONSTRUCTION PLATES
Applicant
ALPHATEC MFG., INC.
42-160 STATE ST.
PALM DESERT,  CA  92211 -5148
Applicant Contact THOMAS A HOGHAUG
Correspondent
ALPHATEC MFG., INC.
42-160 STATE ST.
PALM DESERT,  CA  92211 -5148
Correspondent Contact THOMAS A HOGHAUG
Regulation Number888.3030
Classification Product Code
HRS  
Date Received05/08/1992
Decision Date 08/06/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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