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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Fastener, Fixation, Biodegradable, Hard Tissue
510(k) Number K920188
Device Name THREADED PINS
Applicant
Kirschner Medical Corp.
9690 Deereco Rd.D
Timonium,  MD  21093
Applicant Contact SAM SON
Correspondent
Kirschner Medical Corp.
9690 Deereco Rd.D
Timonium,  MD  21093
Correspondent Contact SAM SON
Classification Product Code
MBJ  
Date Received01/15/1992
Decision Date 05/12/1993
Decision Substantially Equivalent (SESE)
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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