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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name File
510(k) Number K931733
Device Name INTERMEDICS ORTHOPEDICS REAMERS
Applicant
Intermedics Orthopedics
1300 E. Anderson Ln.
Bldg. C
Austin,  TX  78752
Applicant Contact JOANN RINGER
Correspondent
Intermedics Orthopedics
1300 E. Anderson Ln.
Bldg. C
Austin,  TX  78752
Correspondent Contact JOANN RINGER
Regulation Number888.4540
Classification Product Code
HTP  
Date Received04/07/1993
Decision Date 01/26/1994
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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