OSSICULAR PROSTHESIS: 8 PARTIAL, 3 TOTAL— 510(k) K884884

Name: FDA 510(k) clearance K884884
Creator: U.S. Food and Drug Administration
Published: 1989-06-16

Substantially Equivalent

Porex Technologies Corp. of Georgia

FDA 510(k) clearance K884884 for OSSICULAR PROSTHESIS: 8 PARTIAL, 3 TOTAL, Substantially Equivalent on 1989-06-16. Applicant: Porex Technologies Corp. of Georgia. Device class: 2.

Clearance details

Applicant: Porex Technologies Corp. of Georgia
Product code: Code ETA
Device class: Class 2
Regulation: 21 CFR 874.3495
Advisory panel: Ear, Nose, Throat
Date received: 1988-11-22
Decision date: 1989-06-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fairburn, GA, US

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