BONGROS HA— 510(k) K090793

Substantially Equivalent

Bioalpha, Inc.

FDA 510(k) clearance K090793 for BONGROS HA, Substantially Equivalent on 2009-05-19. Applicant: Bioalpha, Inc.. Device class: 2.

Clearance details

Applicant: Bioalpha, Inc.
Product code: Code LYC
Device class: Class 2
Regulation: 21 CFR 872.3930
Advisory panel: Dental
Date received: 2009-03-24
Decision date: 2009-05-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seongnam, KR

Download summary PDF View on FDA.gov ↗

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