AROMAPATCH— 510(k) K984345

Substantially Equivalent

Envis, Inc.

FDA 510(k) clearance K984345 for AROMAPATCH, Substantially Equivalent on 1999-03-19. Applicant: Envis, Inc.. Device class: 1.

Clearance details

Applicant: Envis, Inc.
Product code: Code LRD
Device class: Class 1
Regulation: 21 CFR 874.5220
Advisory panel: Ear, Nose, Throat
Date received: 1998-12-04
Decision date: 1999-03-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Asheville, NC, US

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