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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 K942660
Device Name HALL MICROCHOICE ELECTRIC POWERED SYSTEM
Applicant
Hall Surgical, Division of Zimmer, Inc.
1170 Mark Ave.
Carpinteria,  CA  93013
Applicant Contact TERRY FENANDEZ
Correspondent
Hall Surgical, Division of Zimmer, Inc.
1170 Mark Ave.
Carpinteria,  CA  93013
Correspondent Contact TERRY FENANDEZ
Regulation Number878.4820
Classification Product Code
HWE  
Date Received06/06/1994
Decision Date 09/07/1994
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
Recalls CDRH Recalls
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