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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Template
510(k) Number K894228
Device Name KRONNER SPHERICAL CUTTERS
Applicant
KRONNER MEDICAL
544 WEST UMPQUA
SUITE 104
ROSEBURG,  OR  97470
Correspondent
KRONNER MEDICAL
544 WEST UMPQUA
SUITE 104
ROSEBURG,  OR  97470
Regulation Number888.4800
Classification Product Code
HWT  
Date Received06/19/1989
Decision Date 07/23/1990
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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