BII-PLAST— 510(k) K934947

Substantially Equivalent

Bio-Interfaces, Inc.

FDA 510(k) clearance K934947 for BII-PLAST, Substantially Equivalent on 1994-01-26. Applicant: Bio-Interfaces, Inc.. Device class: 2.

Clearance details

Applicant: Bio-Interfaces, Inc.
Product code: Code LYC
Device class: Class 2
Regulation: 21 CFR 872.3930
Advisory panel: Dental
Date received: 1993-10-18
Decision date: 1994-01-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

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