BIOSPONGE RECONSTRUCTION DISCS— 510(k) K771727

Substantially Equivalent

Xomed, Inc.

FDA 510(k) clearance K771727 for BIOSPONGE RECONSTRUCTION DISCS, Substantially Equivalent on 1977-09-26. Applicant: Xomed, Inc.. Device class: 2.

Clearance details

Applicant: Xomed, Inc.
Product code: Code JOF
Device class: Class 2
Regulation: 21 CFR 874.3620
Advisory panel: Ear, Nose, Throat
Date received: 1977-09-13
Decision date: 1977-09-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Arnold, MO, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JOF

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K083621 — MEDPOR CUSTOMIZED SURGICAL IMPLANT2009-02-03
K002629 — SILMAX CONTOUR CARVING BLOCK IMPLANT2000-11-20
K771726 — BIOSPONGE STAPES PISTON1977-09-26

More clearances from Xomed, Inc.

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K002828 — XPS NITRO SYSTEM2000-10-17
K002897 — TITANIUM MIDDLE EAR PROSTHESES2000-10-11
K993653 — MICRO-FRANCE TROCARS AND ACCESSORIES2000-06-09

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