FULL ITE, LOW PROFILE, HELIX, CANAL COMBIN/SD CANA— 510(k) K894176

Substantially Equivalent

Precision Hearing Instruments

FDA 510(k) clearance K894176 for FULL ITE, LOW PROFILE, HELIX, CANAL COMBIN/SD CANA, Substantially Equivalent on 1989-11-03. Applicant: Precision Hearing Instruments.

Clearance details

Applicant: Precision Hearing Instruments
Product code: Code ESD
Advisory panel: Ear, Nose, Throat
Date received: 1989-06-15
Decision date: 1989-11-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rocky Point, NY, US

Download summary PDF View on FDA.gov ↗

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