IRRIGATION/SUCTION PROBE

Catheter, Irrigation

SURGICAL INSTRUMENT, INC.

The following data is part of a premarket notification filed by Surgical Instrument, Inc. with the FDA for Irrigation/suction Probe.

Pre-market Notification Details

Device IDK923667
510k NumberK923667
Device Name:IRRIGATION/SUCTION PROBE
ClassificationCatheter, Irrigation
Applicant SURGICAL INSTRUMENT, INC. 1030 RICHFIELD RD. Placentia,  CA  92670
ContactDon W Haar
CorrespondentDon W Haar
SURGICAL INSTRUMENT, INC. 1030 RICHFIELD RD. Placentia,  CA  92670
Product CodeGBX  
CFR Regulation Number878.4200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-07-22
Decision Date1993-04-23

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