VERA 103— 510(k) K897143

Substantially Equivalent

Madsen North America, Inc.

FDA 510(k) clearance K897143 for VERA 103, Substantially Equivalent on 1990-04-27. Applicant: Madsen North America, Inc.. Device class: 2.

Clearance details

Applicant: Madsen North America, Inc.
Product code: Code LYN
Device class: Class 2
Regulation: 21 CFR 874.1050
Advisory panel: Ear, Nose, Throat
Date received: 1989-12-27
Decision date: 1990-04-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: North Tonawanda, NY, US

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Recent devices under product code LYN

K950995 — SENSICARE SYNTHETIC, SURGICAL GLOVE LINER1995-06-28
K880259 — VISUAL REINFORCE. AUDIO CASSETTE UNIT: BASIC & ADV1989-04-03

More clearances from Madsen North America, Inc.

K896710 — MIDIMATE 6221990-04-13
K896401 — MICROMATE 3041990-03-27

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