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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Washer, Bolt Nut
510(k) Number K843368
Device Name KAPP SPINAL BUTTON
Applicant
KAPP SURGICAL INSTRUMENT, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
KAPP SURGICAL INSTRUMENT, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number888.3030
Classification Product Code
HTN  
Date Received08/28/1984
Decision Date 09/12/1984
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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