IRRIGATION/ASPIRATION PACK

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INTERMEDICS INTRAOCULAR, INC.

The following data is part of a premarket notification filed by Intermedics Intraocular, Inc. with the FDA for Irrigation/aspiration Pack.

Pre-market Notification Details

Device IDK832525
510k NumberK832525
Device Name:IRRIGATION/ASPIRATION PACK
Classification510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products   510(k) Premarket Notification Var MP = { Version: '1.0.22', Domains: {'es':'esp.fda.gov'}, SrcLang: 'en', UrlLang: 'mp_js_current_la
Applicant INTERMEDICS INTRAOCULAR, INC. 4221 Richmond Rd., N.W. Walker,  MI  49534
Product Code510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood &
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1983-07-29
Decision Date1983-10-04

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