ORTHODONTIC ELASTOMER— 510(k) K932319

Substantially Equivalent

Gac Intl., Inc.

FDA 510(k) clearance K932319 for ORTHODONTIC ELASTOMER, Substantially Equivalent on 1993-09-20. Applicant: Gac Intl., Inc.. Device class: 1.

Clearance details

Applicant: Gac Intl., Inc.
Product code: Code ECI
Device class: Class 1
Regulation: 21 CFR 872.5410
Advisory panel: Dental
Date received: 1993-05-11
Decision date: 1993-09-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Central Islip, NY, US

Download summary PDF View on FDA.gov ↗

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K943419 — ORTHODONTIC ELASTOMERIC LAGATURE MODULE1995-05-24
K943417 — ORTHODONTIC ELASTOMERIC TUBE/THREAD1995-05-23

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K932825 — MICROARCH GOLD BRACKET1994-05-09
K932025 — ION-IMPLANTED NEO SENTALLOY1993-09-13

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