TBW— 510(k) K010545

Substantially Equivalent

Tri-Med, Inc.

FDA 510(k) clearance K010545 for TBW, Substantially Equivalent on 2001-06-06. Applicant: Tri-Med, Inc.. Device class: 2.

Clearance details

Applicant: Tri-Med, Inc.
Product code: Code NDL
Device class: Class 2
Regulation: 21 CFR 888.3040
Advisory panel: Orthopedic
Date received: 2001-02-23
Decision date: 2001-06-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kailua,, HI, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code NDL

K010847 — K'FIX2001-06-19

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K875224 — HUDSON CRANINAL BURRS1988-01-28
K850745 — TRI-MED MODEL 112 MOISTURE TRAP1985-04-02

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