SOFT GRIP UNI-HANDLE— 510(k) K823913

Substantially Equivalent

Treace Medical, Inc.

FDA 510(k) clearance K823913 for SOFT GRIP UNI-HANDLE, Substantially Equivalent on 1983-01-26. Applicant: Treace Medical, Inc.. Device class: 1.

Clearance details

Applicant: Treace Medical, Inc.
Product code: Code EJB
Device class: Class 1
Regulation: 21 CFR 872.4565
Advisory panel: Dental
Date received: 1982-12-28
Decision date: 1983-01-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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More clearances from Treace Medical, Inc.

K883727 — BUCKET PROSTHESIS PORP1989-01-13
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K873154 — TREACE MAGNUM OTO-TOOL SYSTEM1987-09-04
K872000 — EYE GARD1987-07-21

Data sourced from openFDA. This site is unofficial and independent of the FDA.