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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
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