LRM PRODUCES GUIDEWIRES ON AN OEM BASIS FOR MANUFACTURERS,KIT ASSEMBLERS, AND DISTRIBUTORS.— 510(k) K960866

Substantially Equivalent

Lake Region Mfg., Inc.

FDA 510(k) clearance K960866 for LRM PRODUCES GUIDEWIRES ON AN OEM BASIS FOR MANUFACTURERS,KIT ASSEMBLERS, AND DISTRIBUTORS., Substantially Equivalent on 1996-04-05. 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
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Chaska, MN, US
Download summary PDFView on FDA.gov ↗

Recent devices under product code KNY

view all

More clearances from Lake Region Mfg., Inc.

view all

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