SERIES TEN THOUSAND MASTER

Instrument, Vitreous Aspiration And Cutting, Ac-powered

COOPERVISION, INC.

The following data is part of a premarket notification filed by Coopervision, Inc. with the FDA for Series Ten Thousand Master.

Pre-market Notification Details

Device IDK861380
510k NumberK861380
Device Name:SERIES TEN THOUSAND MASTER
ClassificationInstrument, Vitreous Aspiration And Cutting, Ac-powered
Applicant COOPERVISION, INC. 17701 COWAN AVE.P. O. BOX 19587 Irvine,  CA  92713
ContactDonald E Packer
CorrespondentDonald E Packer
COOPERVISION, INC. 17701 COWAN AVE.P. O. BOX 19587 Irvine,  CA  92713
Product CodeHQE  
CFR Regulation Number886.4150 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-04-14
Decision Date1986-07-11

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