HEMA-GLU— 510(k) K951220

Substantially Equivalent

Health-Dent Intl., Inc.

FDA 510(k) clearance K951220 for HEMA-GLU, Substantially Equivalent on 1995-05-12. Applicant: Health-Dent Intl., Inc.. Device class: 2.

Clearance details

Applicant: Health-Dent Intl., Inc.
Product code: Code KLE
Device class: Class 2
Regulation: 21 CFR 872.3200
Advisory panel: Dental
Date received: 1995-03-20
Decision date: 1995-05-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Northlake, IL, US

Download summary PDF View on FDA.gov ↗

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