RESTORE (AKA RE/STOR)— 510(k) K983164

Substantially Equivalent

Nebl, Inc.

FDA 510(k) clearance K983164 for RESTORE (AKA RE/STOR), Substantially Equivalent on 1999-03-05. 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: 1998-09-10
Decision date: 1999-03-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Worcester, 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.