NATAL-TEC ESTRIOL— 510(k) K811371

Substantially Equivalent

Armkel, LLC

FDA 510(k) clearance K811371 for NATAL-TEC ESTRIOL, Substantially Equivalent on 1981-05-29. Applicant: Armkel, LLC. Device class: 1.

Clearance details

Applicant: Armkel, LLC
Product code: Code CGI
Device class: Class 1
Regulation: 21 CFR 862.1265
Advisory panel: Clinical Chemistry
Date received: 1981-05-14
Decision date: 1981-05-29
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.