SYSTEMS PLUS

Instrument, Vitreous Aspiration And Cutting, Ac-powered

UNITED SURGICAL CORP.

The following data is part of a premarket notification filed by United Surgical Corp. with the FDA for Systems Plus.

Pre-market Notification Details

Device IDK860014
510k NumberK860014
Device Name:SYSTEMS PLUS
ClassificationInstrument, Vitreous Aspiration And Cutting, Ac-powered
Applicant UNITED SURGICAL CORP. 15500-A ROCKFIELD BLVD. Irvine,  CA  92718
ContactTerry F Herbeck
CorrespondentTerry F Herbeck
UNITED SURGICAL CORP. 15500-A ROCKFIELD BLVD. Irvine,  CA  92718
Product CodeHQE  
CFR Regulation Number886.4150 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-01-03
Decision Date1986-03-05

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