SMARTBOND— 510(k) K981036

Substantially Equivalent

Gac Intl., Inc.

FDA 510(k) clearance K981036 for SMARTBOND, Substantially Equivalent on 1999-04-05. Applicant: Gac Intl., Inc.. Device class: 2.

Clearance details

Applicant: Gac Intl., Inc.
Product code: Code DYH
Device class: Class 2
Regulation: 21 CFR 872.3750
Advisory panel: Dental
Date received: 1998-03-19
Decision date: 1999-04-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Central Islip, NY, 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.