GIBSON ENDOLYMPHATIC SHUNT— 510(k) K897049

Substantially Equivalent

Hood Laboratories

FDA 510(k) clearance K897049 for GIBSON ENDOLYMPHATIC SHUNT, Substantially Equivalent on 1990-03-16. Applicant: Hood Laboratories. Device class: 2.

Clearance details

Applicant: Hood Laboratories
Product code: Code ESZ
Device class: Class 2
Regulation: 21 CFR 874.3820
Advisory panel: Ear, Nose, Throat
Date received: 1989-12-18
Decision date: 1990-03-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pembroke, MA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code ESZ

K974224 — ENDOLYMPHATIC SAC TO MASTOID T-SHUNT1998-01-27
K952227 — C-FLEX ENDOLYMPHATIC SHUNT1995-06-16
K834094 — AUSTIN ENDOLYMPH DISPERSMENT SHUNT1984-09-20

More clearances from Hood Laboratories

K921452 — ACOUSTIC RHINOMETER1993-07-08
K920994 — HOOD NASAL SEPTAL BUTTON1992-05-15
K905703 — KRUPIN EYE VALVE WITH DISK1991-03-15
K904821 — ELIACHAR MODIFIED ESOPHAGEAL STENT1991-01-14
K897059 — HOOD SPEAKING VALVE1990-03-12

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