SILICONE

510(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

TREACE MEDICAL, INC.

The following data is part of a premarket notification filed by Treace Medical, Inc. with the FDA for Silicone.

Pre-market Notification Details

Device IDK844377
510k NumberK844377
Device Name:SILICONE
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 TREACE MEDICAL, INC. SUITE 400 22 NORTH SECOND STREET Memphis,  TN  38103
ContactWilliam H Thomas
CorrespondentWilliam H Thomas
TREACE MEDICAL, INC. SUITE 400 22 NORTH SECOND STREET Memphis,  TN  38103
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 Received1984-11-13
Decision Date1985-03-18

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00643169945395 K844377 000
00681490070300 K844377 000

Trademark Results [SILICONE]

Mark Image

Registration | Serial
Company
Trademark
Application Date
SILICONE
SILICONE
97565120 not registered Live/Pending
Deng Yuequn
2022-08-25
SILICONE
SILICONE
90605099 not registered Live/Pending
Huimin Sun
2021-03-26

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