BIOGLASS OSSICULAR RECONSTRUCTION PROSTH— 510(k) K843461

Substantially Equivalent

American Biomaterials Corp.

FDA 510(k) clearance K843461 for BIOGLASS OSSICULAR RECONSTRUCTION PROSTH, Substantially Equivalent on 1985-01-09. Applicant: American Biomaterials Corp.. Device class: 2.

Clearance details

Applicant
American Biomaterials Corp.
Product code
Code ETA
Device class
Class 2
Regulation
21 CFR 874.3495
Advisory panel
Ear, Nose, Throat
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Princeton, NJ, US
Download summary PDFView on FDA.gov ↗

Recent devices under product code ETA

view all

More clearances from American Biomaterials Corp.

view all

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