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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Rod, Fixation, Intramedullary And Accessories
510(k) Number K952534
Device Name TENTATIVELY POLARUS EX ROD
Applicant
Acu-Med, Inc.
10950 SW 5th, Suite 170
Beaveton,  OR  97005
Applicant Contact SHARI L JEFFERS
Correspondent
Acu-Med, Inc.
10950 SW 5th, Suite 170
Beaveton,  OR  97005
Correspondent Contact SHARI L JEFFERS
Regulation Number888.3020
Classification Product Code
HSB  
Date Received06/01/1995
Decision Date 07/13/1995
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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