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..

Clearance details

Applicant: Insight Medical Corp.
Product code: Code MNG
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 ↗

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