AFTERLOADING GYNECOLOGICAL APPLICATOR— 510(k) K813230

Substantially Equivalent

Esi

FDA 510(k) clearance K813230 for AFTERLOADING GYNECOLOGICAL APPLICATOR, Substantially Equivalent on 1981-12-29. Applicant: Esi. Device class: 1.

Clearance details

Applicant: Esi
Product code: Code IWJ
Device class: Class 1
Regulation: 21 CFR 892.5650
Advisory panel: Radiology
Date received: 1981-11-10
Decision date: 1981-12-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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