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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cerclage, Fixation
510(k) Number K850631
Device Name KIRSCHNER ORTHOPEDIC WIRE, EYELET CERCLAGE WIRES
Applicant
Kirschner Medical Corp.
Manager Pro Tem
4230 Trenton Ln.
Plymouth,  MN  55441
Applicant Contact KAREN A YOUNG
Correspondent
Kirschner Medical Corp.
Manager Pro Tem
4230 Trenton Ln.
Plymouth,  MN  55441
Correspondent Contact KAREN A YOUNG
Regulation Number888.3010
Classification Product Code
JDQ  
Date Received02/19/1985
Decision Date 05/01/1985
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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