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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Reamer
510(k) Number K832686
Device Name MULTIPLE MANUAL SURGICAL INSTRUMENTS
Applicant
Hirata Sangyo Co. USA, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Hirata Sangyo Co. USA, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number888.4540
Classification Product Code
HTO  
Date Received08/02/1983
Decision Date 10/14/1983
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
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