HALL IRRIGATION SYSTEM

Catheter, Irrigation

HALL SURGICAL, DIVISION OF ZIMMER, INC.

The following data is part of a premarket notification filed by Hall Surgical, Division Of Zimmer, Inc. with the FDA for Hall Irrigation System.

Pre-market Notification Details

Device IDK852143
510k NumberK852143
Device Name:HALL IRRIGATION SYSTEM
ClassificationCatheter, Irrigation
Applicant HALL SURGICAL, DIVISION OF ZIMMER, INC. P.O. BOX 899 `anta Barbara,  CA  93102
ContactDavid D Wellington
CorrespondentDavid D Wellington
HALL SURGICAL, DIVISION OF ZIMMER, INC. P.O. BOX 899 `anta Barbara,  CA  93102
Product CodeGBX  
CFR Regulation Number878.4200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-05-16
Decision Date1985-06-26

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