FEMASSIST URINARY DEVICE— 510(k) K963858

Substantially Equivalent

Insight Medical Corp.

FDA 510(k) clearance K963858 for FEMASSIST URINARY DEVICE, Substantially Equivalent on 1997-10-21. Applicant: Insight Medical Corp.. Device class: 1.

Clearance details

Applicant: Insight Medical Corp.
Product code: Code MNG
Device class: Class 1
Regulation: 21 CFR 876.5160
Advisory panel: Gastroenterology, Urology
Date received: 1996-09-25
Decision date: 1997-10-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bolton, MA, US

Download summary PDF View on FDA.gov ↗

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