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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Component, Traction, Invasive
510(k) Number K840856
Device Name MODULAR CONSTRUCT FRAME EXTERNAL FIXA
Applicant
Precision Medical Devices, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Precision Medical Devices, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number888.3040
Classification Product Code
JEC  
Date Received02/24/1984
Decision Date 04/25/1984
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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