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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
510(k) Number K864929
Device Name HALL (R) MICRO E POWERED SURGICAL INSTRUMENT SYST
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 Number878.4820
Classification Product Code
HWE  
Date Received12/16/1986
Decision Date 01/28/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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