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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Burr, Orthopedic
510(k) Number K862529
Device Name HALL STERILE BUR
Applicant
Hall Surgical, Division of Zimmer, Inc.
P.O. Box 899
`Anta Barbara,  CA  93102
Applicant Contact DAVID D WELLINGTON
Correspondent
Hall Surgical, Division of Zimmer, Inc.
P.O. Box 899
`Anta Barbara,  CA  93102
Correspondent Contact DAVID D WELLINGTON
Regulation Number888.4540
Classification Product Code
HTT  
Date Received07/02/1986
Decision Date 07/15/1986
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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