GLENROE CHAIN— 510(k) K980053

Substantially Equivalent

Glenroe Technologies

FDA 510(k) clearance K980053 for GLENROE CHAIN, Substantially Equivalent on 1998-02-24. Applicant: Glenroe Technologies. Device class: 1.

Clearance details

Applicant: Glenroe Technologies
Product code: Code ECI
Device class: Class 1
Regulation: 21 CFR 872.5410
Advisory panel: Dental
Date received: 1998-01-06
Decision date: 1998-02-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bradenton, FL, US

Download summary PDF View on FDA.gov ↗

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K973495 — GLENROE GLOW IN DARK ELASTOMERIC LIGATURES1997-12-01
K943419 — ORTHODONTIC ELASTOMERIC LAGATURE MODULE1995-05-24
K943417 — ORTHODONTIC ELASTOMERIC TUBE/THREAD1995-05-23
K943418 — ORTHODONTIC ELASTOMERIC SEPARATOR MODULE1995-05-23

More clearances from Glenroe Technologies

K945535 — GLENROE ORTHO-SIL1995-01-27
K924351 — GLENROE ELASTIBITE STIMULATOR1994-01-06
K932920 — GLENROE PLASTIC BRACKET1993-08-24
K924140 — TUFF TIES1993-04-27
K924139 — GLENROE ORTHO SEPS1993-04-08

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