BISTITE II SC— 510(k) K991711

Substantially Equivalent

Tokuyama America, Inc.

FDA 510(k) clearance K991711 for BISTITE II SC, Substantially Equivalent on 1999-07-07. Applicant: Tokuyama America, Inc.. Device class: 2.

Clearance details

Applicant: Tokuyama America, Inc.
Product code: Code EMA
Device class: Class 2
Regulation: 21 CFR 872.3275
Advisory panel: Dental
Date received: 1999-05-19
Decision date: 1999-07-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, 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.