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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 K002486
Device Name PRECIMED TRAUMA SYSTEM
Applicant
Patrick Berdoz
50 Devyn Dr.
Chester Springs,  PA  19425
Applicant Contact PATRICK BERDOZ
Correspondent
Patrick Berdoz
50 Devyn Dr.
Chester Springs,  PA  19425
Correspondent Contact PATRICK BERDOZ
Regulation Number888.3030
Classification Product Code
HRS  
Date Received08/14/2000
Decision Date 11/09/2000
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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