MESIAL LOOP BAR— 510(k) K933542

Substantially Equivalent

Gac Intl., Inc.

FDA 510(k) clearance K933542 for MESIAL LOOP BAR, Substantially Equivalent on 1994-08-05. Applicant: Gac Intl., Inc.. Device class: 1.

Clearance details

Applicant: Gac Intl., Inc.
Product code: Code ECO
Device class: Class 1
Regulation: 21 CFR 872.5410
Advisory panel: Dental
Date received: 1993-07-20
Decision date: 1994-08-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Central Islip, NY, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code ECO

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K844234 — ACTIVE VERTICAL CORRECTOR APPLIANCE1985-01-04
K843550 — ORTHOMAG MAGNETIC FORCE SYSTEM1984-12-21
K843344 — ACTIVE VERTICAL CORRECTOR ACTIVE BITE1984-12-03

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K932319 — ORTHODONTIC ELASTOMER1993-09-20
K932025 — ION-IMPLANTED NEO SENTALLOY1993-09-13

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