DENTAL DAM— 510(k) K954990

Substantially Equivalent

The Hygenic Corp.

FDA 510(k) clearance K954990 for DENTAL DAM, Substantially Equivalent on 1996-01-26. Applicant: The Hygenic Corp.. Device class: 1.

Clearance details

Applicant: The Hygenic Corp.
Product code: Code EIE
Device class: Class 1
Regulation: 21 CFR 872.6300
Advisory panel: Dental
Date received: 1995-10-31
Decision date: 1996-01-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Akron, OH, US

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