PEC IMPLANT— 510(k) K913768

Substantially Equivalent

Applied Biomaterial Technologies

FDA 510(k) clearance K913768 for PEC IMPLANT, Substantially Equivalent on 1992-02-03. Applicant: Applied Biomaterial Technologies. Device class: 2.

Clearance details

Applicant: Applied Biomaterial Technologies
Product code: Code MIC
Device class: Class 2
Regulation: 21 CFR 874.3620
Advisory panel: Ear, Nose, Throat
Date received: 1991-08-22
Decision date: 1992-02-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Silverdale, WA, US

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