HELP-MATE— 510(k) K813249

Substantially Equivalent

G & W Applied Science Laboratories

FDA 510(k) clearance K813249 for HELP-MATE, Substantially Equivalent on 1981-12-03. Applicant: G & W Applied Science Laboratories. Device class: 1.

Clearance details

Applicant: G & W Applied Science Laboratories
Product code: Code ESD
Device class: Class 1
Regulation: 21 CFR 874.3300
Advisory panel: Ear, Nose, Throat
Date received: 1981-11-18
Decision date: 1981-12-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, 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.