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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Pin, Fixation, Smooth
510(k) Number K831005
Device Name WIRE & STEINMAN PINS
Applicant
Kirschner Medical Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Kirschner Medical Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number888.3040
Classification Product Code
HTY  
Date Received03/30/1983
Decision Date 05/18/1983
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
Recalls CDRH Recalls
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