ONCE TM— 510(k) K800162

Substantially Equivalent

G.D. Searle and Co.

FDA 510(k) clearance K800162 for ONCE TM, Substantially Equivalent on 1980-02-11. Applicant: G.D. Searle and Co.. Device class: 2.

Clearance details

Applicant: G.D. Searle and Co.
Product code: Code HDW
Device class: Class 2
Regulation: 21 CFR 884.5350
Advisory panel: Obstetrics/Gynecology
Date received: 1980-01-25
Decision date: 1980-02-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, 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.