RESTORE (A.K.A. CAPSURE)— 510(k) K971359

Substantially Equivalent

Nebl, Inc.

FDA 510(k) clearance K971359 for RESTORE (A.K.A. CAPSURE), Substantially Equivalent on 1997-11-14. Applicant: Nebl, Inc.. Device class: 1.

Clearance details

Applicant: Nebl, Inc.
Product code: Code MNG
Device class: Class 1
Regulation: 21 CFR 876.5160
Advisory panel: Gastroenterology, Urology
Date received: 1997-04-11
Decision date: 1997-11-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Worcester, MA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code MNG

K010365 — ORTHO CONTROL FEMALE URINARY CONTROL DEVICE2001-04-30
K983164 — RESTORE (AKA RE/STOR)1999-03-05
K974600 — UROMED PATCH1998-03-31
K974645 — FEMASSIST FLEXIBLE1998-02-12
K963858 — FEMASSIST URINARY DEVICE1997-10-21

More clearances from Nebl, Inc.

K954959 — CAP-AID1995-12-06

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