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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Blade, Saw, Surgical, Cardiovascular
510(k) Number K862474
Device Name HALL STERNUM SAW
Applicant
Hall Surgical, Division of Zimmer, Inc.
P.O. Box 899
`Anta Barbara,  CA  93102
Applicant Contact DAVID WELLINGTON
Correspondent
Hall Surgical, Division of Zimmer, Inc.
P.O. Box 899
`Anta Barbara,  CA  93102
Correspondent Contact DAVID WELLINGTON
Regulation Number878.4820
Classification Product Code
DWH  
Date Received06/30/1986
Decision Date 07/17/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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