The following data is part of a premarket notification filed by Treace Medical, Inc. with the FDA for Silicone.
Device ID | K844377 |
510k Number | K844377 |
Device Name: | SILICONE |
Classification | 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 |
Applicant | TREACE MEDICAL, INC. SUITE 400 22 NORTH SECOND STREET Memphis, TN 38103 |
Contact | William H Thomas |
Correspondent | William H Thomas TREACE MEDICAL, INC. SUITE 400 22 NORTH SECOND STREET Memphis, TN 38103 |
Product Code | 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 & |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-11-13 |
Decision Date | 1985-03-18 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00643169945395 | K844377 | 000 |
00681490070300 | K844377 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() SILICONE 97565120 not registered Live/Pending |
Deng Yuequn 2022-08-25 |
![]() SILICONE 90605099 not registered Live/Pending |
Huimin Sun 2021-03-26 |