BII-PORE(TM) CANAL WALL PROSTHESIS— 510(k) K934049

Name: FDA 510(k) clearance K934049
Creator: U.S. Food and Drug Administration
Published: 1994-07-19

Substantially Equivalent

Bio-Interfaces, Inc.

FDA 510(k) clearance K934049 for BII-PORE(TM) CANAL WALL PROSTHESIS, Substantially Equivalent on 1994-07-19. 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: 1993-08-19
Decision date: 1994-07-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

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