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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 K790307
Device Name FLEXIBLE REAMER, GUIDE WIRE SYSTEM
Applicant
3M Company
8124 Pacific Ave.
White City,  OR  97503
Correspondent
3M Company
8124 Pacific Ave.
White City,  OR  97503
Regulation Number888.4540
Classification Product Code
HTO  
Date Received02/13/1979
Decision Date 02/22/1979
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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