LIFETEK IUI CATHETER— 510(k) K921518

Substantially Equivalent

Lifetek Medical, Inc.

FDA 510(k) clearance K921518 for LIFETEK IUI CATHETER, Substantially Equivalent on 1994-05-10. Applicant: Lifetek Medical, Inc.. Device class: 2.

Clearance details

Applicant: Lifetek Medical, Inc.
Product code: Code MFD
Device class: Class 2
Regulation: 21 CFR 884.5250
Advisory panel: Obstetrics/Gynecology
Date received: 1992-03-31
Decision date: 1994-05-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Deforest, WI, US

Download summary PDF View on FDA.gov ↗

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