GUIDEWIRE— 510(k) K921200

Substantially Equivalent

Lake Region Mfg., Inc.

FDA 510(k) clearance K921200 for GUIDEWIRE, Substantially Equivalent on 1992-09-04. Applicant: Lake Region Mfg., Inc.. Device class: 2.

Clearance details

Applicant: Lake Region Mfg., Inc.
Product code: Code KNY
Device class: Class 2
Regulation: 21 CFR 876.5130
Advisory panel: Gastroenterology, Urology
Date received: 1992-03-12
Decision date: 1992-09-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chaska, MN, US

Download summary PDF View on FDA.gov ↗

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More clearances from Lake Region Mfg., Inc.

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