DERMATEK 4000— 510(k) K911057

Substantially Equivalent

Anacom General Corp.

FDA 510(k) clearance K911057 for DERMATEK 4000, Substantially Equivalent on 1991-04-05. Applicant: Anacom General Corp.. Device class: 2.

Clearance details

Applicant: Anacom General Corp.
Product code: Code INX
Device class: Class 2
Regulation: 21 CFR 890.5160
Advisory panel: Physical Medicine
Date received: 1991-03-08
Decision date: 1991-04-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Anaheim, CA, 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.