OPHTHALMIC CANNULA

Cannula, Ophthalmic

SURGICAL INSTRUMENT, INC.

The following data is part of a premarket notification filed by Surgical Instrument, Inc. with the FDA for Ophthalmic Cannula.

Pre-market Notification Details

Device IDK881487
510k NumberK881487
Device Name:OPHTHALMIC CANNULA
ClassificationCannula, Ophthalmic
Applicant SURGICAL INSTRUMENT, INC. 1030 RICHFIELD RD. Placentia,  CA  92670
ContactStephen M Priolo
CorrespondentStephen M Priolo
SURGICAL INSTRUMENT, INC. 1030 RICHFIELD RD. Placentia,  CA  92670
Product CodeHMX  
CFR Regulation Number886.4350 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-04-08
Decision Date1988-04-29

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