ComPAS2

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Morgan Scientific, Inc.

The following data is part of a premarket notification filed by Morgan Scientific, Inc. with the FDA for Compas2.

Pre-market Notification Details

Device IDK213872
510k NumberK213872
Device Name:ComPAS2
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 Morgan Scientific, Inc. 151 Essex Street STE 8 Haverhill,  MA  01832
ContactDeborah Cornish
CorrespondentDeborah Cornish
Morgan Scientific, Inc. 151 Essex Street STE 8 Haverhill,  MA  01832
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 Received2021-12-13
Decision Date2022-07-15

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