K001902

Substantially Equivalent

BOJRAB UNIVERSAL LONG IMLANT, MODEL TBD

Applicant: Gyrus Ent LLC
Product code: ETA
Advisory panel: Ear, Nose, Throat
Date received: 2000-06-22
Decision date: 2000-07-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bartlett, TN, US

Download summary PDF View on FDA.gov ↗

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