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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Irrigation
510(k) Number K852143
Device Name HALL IRRIGATION SYSTEM
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 Number878.4200
Classification Product Code
GBX  
Date Received05/16/1985
Decision Date 06/26/1985
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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